News

Innovation for Health 2020 focuses on Brain and AI

Innovation for Health is a conference where the most relevant persons from the life-science industry come together. On 13 February 2020 the seventh edition of the conference will take place in De Doelen ICC, Rotterdam, the Netherlands. Innovation for Health is Netherlands’ premier conference for innovators in Health and Life Sciences.

Zap Surgical raises $81M for RadioSurgical Robot

US-based medical technology company ZAP Surgical Systems has raised $81m in the recently completed equity financing round led by Primavera Capital. Established in 2014, ZAP Surgical Systems is engaged in the design and manufacturing of the ZAP-X radiosurgery platform.

Abbott’s new designation helps advance LVAD market

Abbott Laboratories has won a nod from FDA for a new alternative surgical technique for the HeartMate 3 Left Ventricular Assist Device (LVAD). This technique will not only allow more advanced heart failure patients the opportunity to avoid open-heart surgery, but it will help advance the firm’s position in the LVAD market. 

Using imaging for early intervention after a heart attack

Insights into how the heart recovers after myocardial infarction (heart attack) can be obtained with a new radiotracer that targets fibroblast activity prior to it causing permanent damage. According to research published in the December issue of The Journal of Nuclear Medicine, 68Ga-FAPI-04 positron emission tomography (PET) can effectively image fibroblast activation after myocardial infarction, identifying a time window during which cardiac fibrosis can be prevented and the disease course altered.

Allurion raises $34M for swallowable weight-loss balloon

Gastric weight-loss balloon manufacturer Allurion Technologies has raised $34 million in new funding to boost its commercialization efforts and entry into the U.S. market, pending FDA approval. Through a securities financing and a growth capital term loan, the round was led by Novalis LifeSciences and Romulus Capital, with additional backing from IDO Investments and former Covidien CEO Jose Almeida. The loan was provided by Bridge Bank.

Researchers develop device for swallowing disorders

A wearable monitoring device could make treatment of swallowing disorders easier and more affordable. Researchers from Purdue University have created a skin-mountable sensor sticker that attaches firmly to the neck and is connected with small cables to a wireless transmitter unit.

My first month at… Ormco

The “My first month at…” column will elaborate on the experiences of professionals who recently started their new job in the medical devices industry.

Johnson & Johnson fires up the surgical robotics market

The New Brunswick, N.J.-based company said it would acquire the remaining stake in Verb Surgical, a joint venture the company has with Verily. Earlier, MD+DI asked if Johnson & Johnson was becoming a surgical robotics powerhouse.

Roche launches Zika blood screening test

Roche is launching its in vitro diagnostic test for the Zika virus in countries accepting the CE mark, intended to help screen and protect the global supply of blood donations. For use on the company’s cobas 6800/8800 automated molecular testing systems, the test detects RNA strands that can be traced back to the Zika virus in human plasma samples.

The biggest medtech deals stories of 2019

Medtech has seen some major funding rounds, mergers and acquisitions in 2019. Chloe Kent rounds up some of the most influential digital health deals of 2019.

Dexcom CEO apologizes for remote monitoring outage

Dexcom CEO Kevin Sayer on Friday issued a public apology to the company’s customers for the outage two weeks ago of an app-based service that enables caregivers to remotely monitor diabetes patients’ blood sugar readings taken by a continuous glucose monitor (CGM).

Dekra NL notified body gains EU MDR designation

Dekra Certification B.V., the Netherlands-based notified body of the worldwide product certification firm, is now designated to review products under the European Medical Device Regulation (MDR), per an official listing Saturday in a European Commission database.

Beta Bionics gets FDA breakthrough device status

Boston-based medtech Beta Bionics said Tuesday it received priority review from FDA as part of the Breakthrough Devices Program for its​ iLet system​, which uses mathematical dosing algorithms to automatically control blood sugar levels in people with diabetes.

CMR Surgical to bring on new CEO

U.K.-based robotics developer CMR Surgical plans to bring on a new chief executive at the top of the year, not long after kicking off the global commercialization of its modular, minimally invasive Versius system following a £195 million ($240 million) funding round.

Enzyre and Takeda to develop home haemophilia device

Enzyre has entered into a research collaboration with the Takeda Pharmaceutical Company to develop a device for haemophilia patients to quickly determine their coagulation status at home.

ViewRay investors inks deal with Elekta and Medtronic

Radiation therapy player ViewRay plans to collaborate with Medtronic and Swedish medtech Elekta, the company said Monday, moves it hopes will bolster clinical understanding of its image-guided radiation technology and significantly strengthen its cash position.

Medical device failures brought to light now bolster lawsuit and research

Lorraine Bonner felt as though she was the only one. The surgical staples used to seal her colon after surgery had leaked, she has alleged in a lawsuit, spurring additional surgeries and a long, difficult recovery.

EU Parliament panel adopts MDR delay

A European Parliament committee voted to adopt changes to the EU Medical Device Regulation that would push back the compliance deadline for certain Class I medical devices by four years.

FDA takes action to reduce EtO use

FDA is moving forward on recommendations from a public advisory committee meeting earlier this month regarding ethylene oxide (EtO) sterilization concerns and facility closures. 

DePuy Synthes launches new cervical spine system

Johnson & Johnson’s (NYSE:JNJ) DePuy Synthes said it has launched its Symphony occipito-cervico-thoracic system to expand its portfolio of surgical treatments for the neck and upper back.

Medtronic’s IN.PACT AV DCB receives FDA approval

Medtronic has secured the US Food and Drug Administration (FDA) approval for its IN.PACT AV drug-coated balloon (DCB), a paclitaxel-coated balloon to treat failing arteriovenous (AV) access in patients suffering from end-stage renal disease (ESRD) undergoing dialysis.

EU MDR: the challenge of compliance by may 2020

Medical device manufacturers are less mature in their labeling management compared to peers in other regulated industries, because until now regulatory measures around traceability and reporting have been less pronounced. But with EU MDR (Medical Device Regulations) due to go live in just a few months, how will device manufacturers cope with the numerous implications for patient-facing content?

MyVal transcatheter heart valve reports positive trial

Indian medtech company Meril’s MyVal 1 transcatheter heart valve (THV) has demonstrated a high procedural success rate in a one-month clinical trial.

Sera Prognostics raises $36m to market its PreTRM test

Health diagnostics company Sera Prognostics has secured $36m funds to advance the commercialisation of its PreTRM test. The PreTRM test is a clinically-validated blood test, which offers an early and individual risk prediction for spontaneous preterm birth in asymptomatic and singleton pregnancies.

Invitae to buy DNA-counseling chatbot developer

The genetic testing firm Invitae aims to scale up its ability to provide personal guidance alongside its DNA test results—through the planned, $50 million acquisition of Clear Genetics, developers of digital counseling software.

Exact Sciences closed its acquisition of Genomic Health

Molecular diagnostics firm Exact Sciences has closed its approximately $2.8bn acquisition of genomic diagnostics maker Genomic Health. In July, Exact Sciences signed a definitive agreement to acquire genomic diagnostics maker Genomic Health in a cash-and-stock deal.

World’s first robot-assisted brain aneurysm surgery

A team of Toronto doctors has completed the world’s first brain aneurysm surgery using robotics, leading to hope of better treatment for aneurysm and stroke patients, especially in areas where specialized surgical expertise isn’t available.

Abbott circulatory support system Class I recall

The FDA recently labeled two device recalls as Class I, the most serious, after they were launched by Philips and Abbott earlier this year—including the latter’s CentriMag cardiac support system for open-heart surgeries following the death of a patient. 

Breakthrough tag for tackling biofilm infections

FDA has awarded breakthrough device status to Garwood Medical Devices’ technology for tackling biofilm infections on prosthetic knee implants, the company said.

Medical device maker Stryker to buy Wright Medical

Medical device maker Stryker Corp (SYK.N) said on Monday it would buy smaller rival Wright Medical Group (WMGI.O) for about $4 billion in cash, expanding into the fast-growing business of implants for shoulders and wrists.

FDA pitches black box warning for breast implants

FDA on Wednesday proposed that manufacturers add a black box warning to breast implant products, a move the agency teased earlier this year after convening an advisory panel on a form of cancer some believe is linked to textured versions of the products.

2 companies apply Google AI to patient monitoring

Google has been no stranger to the industry’s rush to bring artificial intelligence (AI) software to healthcare—with programs in diabetic retinopathy, electronic patient records and cancer-seeking CT scans—but now they’re looking to supply the hardware, too.

Fresenius gets breakthrough tag

Fresenius Medical Care North America (NYSE:FMS)  said that it won breakthrough device designation from the FDA for the new hemodialysis system it’s developing.

Fitbit partners up on early atrial fibrillation detection

Fitbit is teaming up with Bristol-Myers Squibb and Pfizer to help bring atrial fibrillation detection capabilities to its line of wearable fitness trackers as part of a larger campaign toward earlier diagnoses among those at higher risk of heart disease and stroke.

Blood-cleaning machine eliminates carbon monoxide

Hemoglobin in the body’s red blood cells binds carbon monoxide 200 times more tightly than it does oxygen, which explains why exposure to the gas can be so deadly.

Research questions safety benefit of robotic colectomies

The use of robotics in colectomies has shot up in recent years but research published in JAMA Surgery questions the value of the high-tech approach over open and laparoscopic procedures.

3M completes $6.7B deal Acelity

3M Co. said Friday it has completed its acquisition of San Antonio medical technology company Acelity Inc. in a transaction valued at about $6.7 billion.

Sandoz drops out of partnership with Pear Therapeutics

Sandoz pulled the plug on its commercialization partnership with Pear Therapeutics, ending its experiment with digital treatments for substance use disorders that first kicked off in April 2018.

Brexit: UK floats device contingency

The U.K. government has described a proposed Medicines and Medical Devices Bill to support the life sciences sector after Brexit, roughly two weeks before a key deadline that could see the country exiting the European Union.

Medtronic stent graft system wins breakthrough designation

A stent graft system being developed by Medtronic for minimally invasive repair of thoracoabdominal aortic aneurysm (TAAA) received breakthrough device designation from FDA, the company announced Tuesday.

Qiagen and Illumina sign 15-year deal for IVD tests

Diagnostic solutions providers Qiagen and Illumina have collaborated to boost the availability and use of next-generation sequencing (NGS)-based in-vitro diagnostic (IVD) tests, including companion diagnostics, for clinical patient management.

Paralysed man moves in mind-reading exoskeleton

A man has been able to move all four of his paralysed limbs with a mind-controlled exoskeleton suit, French researchers report.

BD to appoint new as the medtech’s CEO

BD COO Thomas Polen, 46, will take over as the medtech’s CEO on Jan. 28, 2020, per a unanimous vote by the company’s board of directors announced in a leadership succession plan Thursday.

Australia enforces new regs on all breast implant makers

The Therapeutic Goods Administration is following through on plans to temporarily or permanently remove certain textured breast implants and tissue expanders from the Australian market after concluding a safety review of the devices it initiated in May.

New drug-eluting stent data in patients at high risk for bleeds

In late-breaking clinical data, Medtronic showed that its Resolute Onyx drug-eluting stent showed success in patients at a high risk for bleeding, a group that is often excluded from stent and drug studies.

Virtual reality could improve surgical outcomes

A new study led by UCLA Health in the US has shown that three-dimensional (3D) virtual reality models could improve surgical outcomes by enabling better visualisation of a patient’s anatomy. When tested in preparation for kidney tumour surgeries, the models led to shorter operating times, less blood loss during surgery, and a shorter hospital stay following the procedure.

CMR Surgical raises £195m in Series C round

UK-based medical robotics company CMR Surgical has raised £195m in its Series C funding round, pushing the company value to over £1bn before the launch of its first product.

A swifter way towards 3D-printed organs

20 people die every day waiting for an organ transplant in the United States, and while more than 30,000 transplants are now performed annually, there are over 113,000 patients currently on organ waitlists.

Omron’s HeartGuide: blood pressure monitoring for the modern age

High blood pressure is often managed through at-home self-monitoring, a routine which can be difficult to manage for patients with hectic lifestyles. Now, Japanese medtech giant Omron may have the solution.

Brexit threatens U.K. robotic surgery innovation

The United Kingdom robotic surgery sector is likely to suffer if a U.K. hard split from the European Union hinders cross-border collaborations, according to a study published in BMJ Open on Tuesday. According to the analysis, the U.K. has become one of the most innovative places for robotic surgery on the strength of its collaborations with other EU member states. If the U.K. can replace EU partners with top-performing United States collaborators, Brexit could boost the robotic surgery sector but the researchers said that will likely be very difficult and expensive to achieve.

Hope is not a strategy – Insights from the MedTech Summit

Written by Angela Leek – Medical Devices Community

From 17 until 21 June 2019, the MedTech Summit took place in Brussels. Over 150 expert speakers came together at the Crowne Plaza Hotel to navigate professionals from the industry through current challenges by giving presentations, holding discussions and in-depth case studies. On behalf of the Medical Devices Community, I was present to get insights on the most recent developments.

Biotronik obtains the world’s first MDR certification

The First Class III Medical Device is Certified Under the New European Medical Device Regulation

BIOTRONIK  announced that it is the world’s first manufacturer to receive European Medical Device Regulation (MDR) certification for a Class III (highest risk) medical device. Following a successful conformity assessment, BIOTRONIK also obtained MDR certification for its quality management system.

Studying heart cells with nanovolcanoes

Researchers at EPFL and the University of Bern have developed a groundbreaking method for studying the electrical signals of cardiac muscle cells. The technology has numerous potential applications in basic and applied research – such as improving the search for mechanisms underlying cardiac arrhythmias.

iRhythm links with Verily to help diagnose ‘silent’ afib

Wearable electrocardiogram maker iRhythm Technologies has begun working with Verily Life Sciences to develop ways to better screen, diagnose and manage patients living with so-called “silent” atrial fibrillation.

Abbott launches trial of its tricuspid valve repair device

Abbott has begun its first randomized, pivotal trial to test a new method of fixing leaky tricuspid heart valves, where there are currently no approved minimally invasive repair therapies available.

5G meets medicine: separating fact from fiction

5G has been hailed as the next frontier for medicine, introducing new remote surgery capabilities and expanding patient access to the internet in hospitals. But not everyone is convinced. We take a look at the realistic impact that 5G could have on the industry.

Urine test shows promise for cancer detection

A laboratory study in mice demonstrates that a colour-change urine test based on nanosensors could help detect colon cancer / bowel cancer. Researchers at Imperial College London, UK and Massachusetts Institute of Technology (MIT) in the US developed the new technology to enable early cancer identification.

Elekta fortifies treatment planning offering with acquisition of ProKnow

STOCKHOLM, August 29, 2019 – Elekta (EKTA-B.ST) announced that it has acquired ProKnow Systems, LLC, in order to expand its offering of cloud-based solutions for advanced radiation therapy. With ProKnow’s products, such as ProKnow DS, Elekta’s customers will have access to high-quality, cloud-based, treatment planning analytics to standardize their practices.

FDA approves first spinal tether implant for correcting childhood scoliosis

The FDA approved the first spinal tether medical device to correct the most common form of scoliosis in children and adolescents—a ropelike implant that pulls the vertebrae into shape as the child grows, following the failure of treatments like external braces. Zimmer Biomet’s new tethering system for idiopathic scoliosis is intended for children whose sideways curvature of the spine has become so severe that surgery such as a bone fusion procedure may be necessary.

Researchers develop 3D printing for heart valves

Researchers at Carnegie Mellon University recently developed a method to rebuild components of the human heart using 3D printing. The team of researchers made an advanced version of Freeform Reversible Embedding of Suspended Hydrogels (FRESH) technology in order to 3D print collagen with complexity to construct components of the human heart. The method spans from small blood vessel to valves and beating ventricles. The FRESH technology was recently awarded a U.S. patent and is being licensed to FluidForm.

Tiny lensless endoscope captures 3D images of objects smaller than a cell

Researchers have developed a new self-calibrating endoscope that produces 3D images of objects smaller than a single cell. Without a lens or any optical, electrical or mechanical components, the tip of the endoscope measures just 200 microns across, about the width of a few human hairs twisted together.

As a minimally invasive tool for imaging features inside living tissues, the extremely thin endoscope could enable a variety of research and medical applications. The research will be presented at the Frontiers in Optics + Laser Science (FIO + LS) conference, held September 15-19 in Washington, D.C., U.S.A.

Trump administration delays law to curb unneeded MRIs

Five years after Congress passed a law to reduce unnecessary MRIs, CT scans and other expensive diagnostic imaging tests that could harm patients and waste money, federal officials have yet to implement it. The law requires that doctors consult clinical guidelines set by the medical industry before Medicare will pay for many common exams for enrollees. Health care providers who go way beyond clinical guidelines in ordering these scans (the 5% who order the most tests that are inappropriate) will, under the law, be required after that to get prior approval from Medicare for their diagnostic imaging.

ZipLine’s wound closure alternative outperforms staples

Two recent clinical studies from ZipLine Medical showed that its surgical wound closure system demonstrated improvements in both patient outcomes and overall costs compared to surgical staples. The company’s Zip device is used to help close and hold together the outer skin after deeper layers of sutures are applied within a surgical incision. Its non-invasive, flexible design aims to minimize scarring compared to staples, sutures or glue, while the wound heals following a procedure.

Ethylene oxide sterilization for medical devices

Why Is Ethylene Oxide Used to Sterilize Medical Devices?

Medical devices are sterilized in a variety of ways including using moist heat (steam), dry heat, radiation, ethylene oxide gas, vaporized hydrogen peroxide, and other sterilization methods (for example, chlorine dioxide gas, vaporized peracetic acid, and nitrogen dioxide). Ethylene oxide sterilization is an important sterilization method that manufacturers widely use to keep medical devices safe.

UBS surgeon poll points to neuromodulation market slowdown

Analysts at UBS said the worldwide neuromodulation spinal cord stimulation market appears to be slowing and will likely be down year over year, based on feedback from the bank’s survey of surgeons. Significant deceleration in growth over the past two quarters is due to a lack of new product launches, price discounting, turnover among sales representatives, and use of alternative pain treatments, UBS said. Among device makers, Boston Scientific and Abbott reported weaker spinal cord stimulation growth rates in the second quarter, while Medtronic appeared to be gaining market share, the bank said. Fewer surgeons were using devices from Nevro in the latest survey, compared to the third quarter of 2018, UBS said.

Born in space? The shift in the mission’s program

A follow-up interview with Dr. Egbert Edelbroek – CEO & Founder of SpaceBorn United

In the previous article, we spoke Dr. Edelbroek about the ambitious space missions that his organisation SpaceBorn United is preparing. SpaceBorn United is a biotech and space mission development company. The company wants to contribute to the learning process of human reproduction in space. Currently, when humans are exposed to the many challenges of space, it leaves them unable to reproduce. The mission program is divided into three missions, Ark, Lotus and Cradle. In this article we will dive a little deeper into these missions.

AI improves efficiency and accuracy of digital breast tomosynthesis

Artificial intelligence (AI) helps improve the efficiency and accuracy of an advanced imaging technology used to screen for breast cancer, according to a new study published in the journal Radiology: Artificial Intelligence.

Blood pressure monitoring much easier in the future

Blood pressure monitoring might one day become as easy as taking a video selfie, according to new research in Circulation: Cardiovascular Imaging, an American Heart Association journal.

Two health tech startups among European funding competition winners

Xploro, a digital therapeutics platform developed in Manchester, and Triple Tread, a high-performance tricycle manufacturer based in Congleton, were both winners in the final round of the European Institute of Technology’s (EIT) Health Headstart Awards.

Worrisome increase in some medical scans during pregnancy

Use of medical imaging during pregnancy increased significantly in the United States, a new study has found, with nearly a four-fold rise over the last two decades in the number of women undergoing computed tomography (CT) scans, which expose mothers and fetuses to radiation. Pregnant women are warned to minimize radiation exposure.

Prosthetic arm can sense touch, move with your thoughts

Keven Walgamott had a good “feeling” about picking up the egg without crushing it. What seems simple for nearly everyone else can be more of a Herculean task for Walgamott, who lost his left hand and part of his arm in an electrical accident 17 years ago. But he was testing out the prototype of a high-tech prosthetic arm with fingers that not only can move, they can move with his thoughts. And thanks to a biomedical engineering team at the University of Utah, he “felt” the egg well enough so his brain could tell the prosthetic hand not to squeeze too hard.

Mobile app tests impact of mental health on cognitive performance

Researchers at the University of New South Wales (UNSW) and University College London (UCL) have developed a mobile app which allows users to track how their mood and emotions impact their cognitive performance.

Australia on watch for EU notified bodies shortage

Australia’s Therapeutic Goods Administration (TGA) said it is aware of industry concern about whether a sufficient number of notified bodies will be designated under the new European Union Medical Device Regulation in time for the May 2020 effective date. The Australian regulator said it is monitoring the situation and will consider the impact on manufacturers seeking certification for new products or looking to maintain existing certification. The agency also said it has expanded the range of assessments and approvals from overseas regulators that medical device makers can use when submitting applications for inclusion in the Australian Register of Therapeutic Goods.

Ultrasound-assisted optical imaging to replace endoscopy

Carnegie Mellon University’s Assistant Professor of Electrical and Computer Engineering (ECE) Maysam Chamanzar and ECE Ph.D. student Matteo Giuseppe Scopelliti today published research that introduces a novel technique which uses ultrasound to noninvasively take optical imaging through a turbid medium such as biological tissue to image body’s organs. This new method has the potential to eliminate the need for invasive visual exams using endoscopic cameras.

My first month at… Esaote Europe

The “My first month at…” column will elaborate on the experiences of professionals who recently started their new job in the medical devices industry.

Nanowear to launch trial of heart failure-monitoring underwear

Nanowear said today that it has launched a heart failure management and alert diagnostic validation study of its medical-grade, cloth-based nanosensor technology.

Medtronic to distribute Viz.ai’s stroke-spotting AI imaging software

Medtronic is tapping Viz.ai, a developer of artificial intelligence programs to help spot strokes, for a distribution partnership to bring its technology to more hospitals and centers.

Viz.ai’s software links with CT scanners to identify and triage potential large vessel occlusion strokes, or LVOs, and can automatically notify specialists while providing the radiological images to their smartphones.

New implant uses microcurrent to strengthen heart muscle

A clinical study by the Medical University of Vienna and Vienna General Hospital has demonstrated that Berlin Heals’ electroceutical device can exercise and strengthen the heart muscle in people with cardiomyopathy. The implant delivers a microcurrent to stimulate cell regeneration in the affected heart muscle. This is expected to help patients avoid or delay heart transplant surgery.

3D body mapping device improves post-chemo cell therapy success

Purdue University researchers have developed a 3D mapping technology to monitor and track the behaviour of engineered tissues and cells.

Low-cost retinal scanner could help prevent blindness worldwide

Biomedical engineers at Duke University have developed a low-cost, portable optical coherence tomography (OCT) scanner that promises to bring the vision-saving technology to underserved regions throughout the United States and abroad.

Wearable body patch allows early detection of sepsis

A body-worn monitoring system developed by UK-based Isansys Lifecare has the potential to speed up sepsis diagnosis in hospitals.

Google Doodle honours pioneering heart surgeon René Favaloro

“‘We’ is more important than ‘I.’ In medicine, the advances are always the result of many efforts accumulated over the years,” wrote Dr. René Favaloro, the Argentinian surgeon who introduced coronary artery bypass surgery into clinical practice and is celebrated in today’s Doodle.

GDPR: Study highlights data protection challenges for research

The introduction of laws like the EU General Data Protection Regulation (GDPR) can complicate the operations of scientific journals and funding bodies, according an Uppsala University-led study presented at the annual conference of the European Society of Human Genetics.

AI tool for smart speakers could save lives

Researchers at the University of Washington have developed a new contactless artificial intelligence (AI) tool to monitor at-risk patients for cardiac arrest, even when they’re asleep.

Scientists discover new medical imaging method

In an advance for medical imaging, scientists from University of North Carolina Lineberger Comprehensive Cancer Center have discovered a method for creating radioactive tracers to better track pharmaceuticals in the body as well as image diseases, such as cancer, and other medical conditions.

Parkinson’s disease new discovery could lead to new screening tools

Changes to the serotonin system of the brain could act as a crucial early warning signal for Parkinson’s disease and may lead to the development of new screening tools for the chronic condition.

Music-based therapeutic for stroke survivors

What if the steady beats of music, coupled with personalized neuroscience, could help stroke survivors regain their ability to walk?

AI in ultrasound, threat or chance?

Blog by Stevan Stuit – Former diagnostic radiographer and diagnostic medical sonographer

It is everywhere in the news nowadays; the pros and cons of Artificial Intelligence (AI). The influence of AI on economics, labour and our position.

Autonomous brain-computer interface to enable robotic prosthetics

Engineers at the University of Houston in the US have found that a brain-computer interface (BCI) could allow the development of robotic prosthetics with a more natural performance.

‘Virtual biopsy’ device to detect skin tumours

Using sound vibrations and pulses of near-infrared light, a Rutgers University scientist has developed a new “virtual biopsy” device that can quickly determine a skin lesion’s depth and potential malignancy without using a scalpel.

Ultrasound to enable targeted drug delivery for brain diseases

Columbia Engineering researchers have devised an ultrasound-based technique to restore dopaminergic pathway in the brain of patients with Parkinson’s disease.

Trial stem cell heart patches for damage repair

Researchers from Imperial College London have devised an approach to grow heart patches made of up to 50 million human stem cells as part of a project funded by the British Heart Foundation (BHF).

MedFit 2019

Held on the 25th and 26th of June 2019 in Lille – France, and gathering 700 international participants from over 25 countries, MedFit is the leading European business convention dedicated to innovation partnerships in the fields of medical technology, diagnostics and digital health sector.

Thermo Fisher agrees to terminate $925m Gatan acquisition

Thermo Fisher Scientific has agreed to abandon the proposed acquisition of Gatan from software developer Roper Technologies.

Home-based brain stimulation treatment for depression launches in UK

An at-home, medical-grade brain stimulation headset has launched in the UK, and claims to offer an alternative to pharmacological treatment for depression. The system is used in conjunction with a therapy app. 

Born in space in 2028

Interview with Dr. Egbert Edelbroek – CEO & Founder SpaceBorn United

SpaceBorn United is determined to become the first company that will enable childbirth in space by 2028. Says CEO & Founder, Dr. Egbert Edelbroek: “It is not going to be an easy journey. Space is a hostile environment for living organisms.”

UK researchers test virtual reality technology to detect Alzheimer’s

Researchers at University of Cambridge in the UK have found that virtual reality (VR) could detect early Alzheimer’s disease more accurately compared to existing ‘gold standard’ cognitive tests.

Thinking outside the box: ‘Seeing’ clearer and deeper into live organs

Scientists using a unique approach have developed a new biomedical imaging contrast agent. They say the breakthrough overcomes a major challenge to “seeing” deeper into live tissue, and opens the way for significant improvements in optical imaging technology.

My first month at… Illumina

The “My first month…” column will elaborate on the experiences of professionals who recently started their new job in the medical devices industry.

This article is about the experiences of  Arthur Jacobs (51) who recently started as a Trade Compliance Specialist at Illumina. We asked him a few questions about his first month at Illumina. If you want to know more about the company, Arthur and his experiences working at Illumina. Then keep on reading.

The cold facts about the cold chain in medical devices

Blog by Tim Broekhuizen – Regional Manager, Centre of Excellence, Supply Chain Management (APAC) at DKSH

Tim Broekhuizen is a Dutch national, currently stationed in Asia as Regional Manager, Center of Excellence, Supply Chain Management (APAC) at DKSH.

AI surpasses humans in predicting heart attack and death

An algorithm has learned how to identify imaging patterns correlating to heart attack and death in cardiac patients and can predict the occurrence of these events with superior accuracy to human doctors, according to a study presented at 2019’s International Conference on Nuclear Cardiology and Cardiac CT (ICNC) in Lisbon, Portugal.

All you want to know about risk management and medical devices

Interview with Bijan Elahi – Global Product Risk-Management Consultant and Educator at Medtronic

Bijan Elahi is an engineer, a teacher and an author with one goal: helping people to produce the safest medical products.

CMR surgical’s versius completes initial surgical procedures in humans

UK-based medical equipment maker CMR Surgical has announced the completion of the first series of human surgical procedures using its Versius surgical robotic system as part of a clinical study in India.

Train your brain to eat less sugar

More than half of American adults consume excess added sugars, according to the U.S. Department of Health and Human Services. Major dietary guidelines recommend limiting foods high in added sugars.

Lundbeck strikes $250M Abide buyout, bagging Tourette’s drug

Lundbeck is set to pay $250 million (€223 million) upfront to buy Abide Therapeutics. The deal will give Lundbeck a phase 2a Tourette’s syndrome program, a central nervous system drug discovery platform and a West Coast research hub.

Medtronic introduces new revascularisation device in US

Irish medical device company Medtronic has launched Solitaire X, a revascularisation device intended to treat patients with acute ischemic stroke, in the US.

Study finds Abbott’s Troponin-I blood test predict heart disease risks

Abbott’s new study has found that its High Sensitive Troponin-I blood test is capable of predicting heart disease risks in people with no symptoms.

Scientists develop swallowable self-inflating capsule to help tackle obesity

A team from Nanyang Technological University, Singapore (NTU Singapore) and the National University Health System (NUHS) has developed a self-inflating weight management capsule that could be used to treat obese patients.

Ready for a challenge?

Are you looking for an entry-level job or do you want to change positions in the medical devices sector?

US court orders J&J to pay $120m in damages over pelvic mesh implant

Johnson & Johnson (J&J) subsidiary Ethicon has been ordered to pay $120m in damages by a Philadelphia court after it ruled that its negligently designed pelvic mesh implant caused a Pennsylvania woman to suffer from incontinence and chronic pain, Law360 has reported.

Four ways virtual, augmented reality could change radiology forever

Virtual reality (VR) and augmented reality (AR) technologies have the potential to dramatically change healthcare and could impact the practice of radiology in a number of ways.

AI-driven voice analysis used to diagnose post-traumatic stress disorder

A study published in Depression and Anxiety has revealed that a specially designed artificial intelligence (AI) can diagnose post-traumatic stress disorder (PTSD) through vocal biomarkers.

Making digital tissue imaging better

There’s a low-tech problem troubling the high-tech world of digital pathology imaging.The issue: Even as digital pathology makes rapid advances worldwide

New MRI technology could measure brain function in milliseconds

Scientists have developed a new technique to measure brain function in milliseconds using magnetic resonance imaging (MRI).

Researchers build 3D-printed heart out of patient’s donor cells

Researchers in Israel have printed a three-dimensional human heart using bioinks developed from a patient’s own cells, which they say makes it completely biocompatible with the donor.

New PET imaging biomarker could better predict progression of Alzheimer’s disease

Researchers have discovered a way to better predict progression of Alzheimer’s disease. By imaging microglial activation levels with positron emission tomography (PET), researchers were able to better predict progression of the disease than with beta-amyloid PET imaging, according to a study published in the April issue of the Journal of Nuclear Medicine.

J&J concludes $3.4bn Auris Health acquisition

Johnson & Johnson (J&J) subsidiary Ethicon has closed a $3.4bn acquisition of surgical robotics developer Auris Health.

Laser technology helps researchers scrutinize cancer cells

Devising the best treatment for a patient with cancer requires doctors to know something about the traits of the cancer from which the patient is suffering. But one of the greatest difficulties in treating cancer is that cancer cells are not all the same.

Ultrasound aligns living cells in bioprinted tissues

North Carolina State University researchers have developed a technique to improve the characteristics of engineered tissues by using ultrasound to align living cells during the biofabrication process.

Total Quality Management for Cold Chain: A-SMART and 5C method

In an article on cold chain vaccine delivery, Matthias, D.M. (et al)* state that in developing countries 22% of the healthcare cold chain products are prone to damage during storage. Although Asia is developing, it is yet to be fully matured in various aspects, especially when it comes to cold chain management.

AI improves contouring accuracy for radiation oncology

An artificial intelligence (AI) algorithm can provide accurate, fast, and automated contouring of primary tumor volumes on multiparametric MR images of nasopharyngeal carcinoma patients, potentially improving outcomes from radiation therapy, according to research.

Diattenuation imaging: Promising imaging technique for brain research

A new imaging method provides structural information about brain tissue that was previously difficult to access. Diattenuation Imaging (DI), developed by scientists at Forschungszentrum Jülich and the University of Groningen, allows researchers to differentiate, e.g., regions with many thin nerve fibres from regions with few thick nerve fibres.

Total quality management for cold chain at DKSH

Watch this video to learn more about cold chain management.

At DKSH we understand that cold chain management is about process, assets and people. Learn more about our unique research-based method called: “Total quality management for cold-chain” which ensures that every step in the cold chain is secured across our network of regional distribution centers. 

Cancer imaging technology can help reveal life-threatening pregnancy disorder

An imaging technique used to detect some forms of cancer can also help detect preeclampsia in pregnancy before it becomes a life-threatening condition, a new Tulane study says.

Hydrogel contact lens to treat serious eye disease

Researchers at the University of New Hampshire have created a hydrogel that could one day be made into a contact lens to more effectively treat corneal melting, a condition that is a significant cause for blindness worldwide.

New optical imaging system could be deployed to find tiny tumors

Many types of cancer could be more easily treated if they were detected at an earlier stage. MIT researchers have now developed an imaging system, named “DOLPHIN,” which could enable them to find tiny tumors, as small as a couple of hundred cells, deep within the body.

New Medical Devices Regulation – “Notified Bodies face a huge workload”

Blog by Catherinea Jones – Quality Assurance Specialist

On April 5th, 2017, the EU adopted the new Medical Devices Regulation (MDR), replacing the two existing directives: the Medical Devices Directive (MDD) and Active Implantable Medical Devices Directives (AIMD). What does this change mean for the industry? We spoke to Catherinea Jones, who works as a Quality Assurance Specialist. “This is a massive operation.”

Fresenius Medical Care closes $2bn NxStage Medical acquisition

German dialysis products and services company Fresenius Medical Care has completed the $2bn acquisition of US-based medical devices maker NxStage Medical, after receiving clearance from the US antitrust authorities.

Philips unveils new EPIQ Elite ultrasound line, with vascular imaging capabilities

Philips has launched its new EPIQ Elite ultrasound system, offering a range of diagnostic solutions for different medical specialties, including the company’s first for vascular assessments.

New pill can deliver insulin

An MIT-led research team has developed a drug capsule that could be used to deliver oral doses of insulin, potentially replacing the injections that people with type 1 diabetes have to give themselves every day.

UCI biomedical engineers develop wearable respiration monitor with children’s toy

Researchers at the University of California, Irvine have developed a wearable, disposable respiration monitor that provides high-fidelity readings on a continuous basis. It’s designed to help children with asthma and cystic fibrosis and others with chronic pulmonary conditions.

Ultra ultrasound to transform new tech

A new and extremely sensitive method of measuring ultrasound could revolutionise everything from medical devices to unmanned vehicles. 

J&J launches new intraocular lens for cataract patients in Europe

Johnson & Johnson Vision has launched its TECNIS Eyhance intraocular lens for the treatment of cataracts in European commercial markets.

Going for an MRI scan with tattoos?

According to Weiskopf, Director at the Max Planck Institute for Human Cognitive and Brain Sciences in Leipzig (MPI CBS), .” ..the most important questions for us were: Can we conduct our studies with tattooed subjects without hesitation?

Physics can show us the inside of tumors

A team of physicists at the Institut Lumière Matière (CNRS/Université Claude Bernard Lyon 1), in collaboration with the Cancer Research Center of Lyon (CNRS/INSERM/ Université Claude Bernard Lyon 1//Centre Léon Bérard/Hospices civils de Lyon), has demonstrated the potential, for oncology, of an imaging technique based only on the physical properties of tumors. 

Empatica secures FDA clearance for paediatric use of epilepsy smartband

Massachusetts Institute of Technology (MIT) Media Lab spin-off, Empatica, has received the US Food and Drug Administration (FDA) 510(k) clearance for the use of its Embrace epilepsy smartband for children.

Ares Genetics gains funds to advance AI-based diagnostic

Ares Genetics, a unit of molecular diagnostics developer Curetis, has secured funding from the Vienna Business Agency to support the development of an artificial intelligence (AI)-based diagnostic test called ARESupa.

Surgeons successfully implant rib produced by 3D printer

The patient had a tumour formation in the fifth right rib accompanied by swelling and pain. It was thought to be a congenital disease that could lead to weakening of the chest and problems associated with physical strain, including difficulty breathing.

Physics can show us the inside of tumors

A team of physicists at the Institut Lumière Matière (CNRS/Université Claude Bernard Lyon 1), in collaboration with the Cancer Research Center of Lyon (CNRS/INSERM/ Université Claude Bernard Lyon 1//Centre Léon Bérard/Hospices civils de Lyon), has demonstrated the potential, for oncology, of an imaging technique based only on the physical properties of tumors.

Swedish researchers develop ‘painless’ glucose monitoring system

A research team at KTH Royal Institute of Technology in Sweden is developing a glucose monitoring device that is said to be 50 times smaller than the needles used in existing continuous glucose monitoring (CGM) systems.

Generex to buy Pantheon Medical

Integrated healthcare company Generex Biotechnology has signed a letter of intent (LOI) to acquire surgical devices firm Pantheon Medical – Foot & Ankle. The deal covers all assets, including business operations, accounts receivable and inventory, contracts, and a US Food and Drug Administration (FDA) letter for balanced plating system.

Engineers create an inhalable form of messenger RNA

Messenger RNA, which can induce cells to produce therapeutic proteins, holds great promise for treating a variety of diseases. The biggest obstacle to this approach so far has been finding safe and efficient ways to deliver mRNA molecules to the target cells.

AI predicts cancer patients’ symptoms

Doctors could get a head start treating cancer thanks to new AI developed at the University of Surrey that is able to predict symptoms and their severity throughout the course of a patient’s treatment.

US researchers develop neurostimulator to treat brain disorders

University of California, Berkeley (UC Berkeley) researchers in the US have developed a neurostimulator called WAND to help treat neurological disorders such as epilepsy and Parkinson’s disease.

Living in a Wheelchair

Blog by Jim Ryan – A Quadriplegic

It has been a while since I have added to the blog. I had a very busy November coupled with 10 days of being sick. In December I had a few calm weeks, but the during the Christmas holiday it was quite hectic again. In this blog I will tell you more about my wheelchair, and how I am able to move with it.

Novel imaging technique brings diagnostic potential into operating room

A team of University of Illinois at Urbana-Champaign researchers led by Professor Stephen Boppart has successfully visualised the tumor microenvironment of human breast tissue shortly after it was surgically removed from a patient in the operating room. The researchers achieved this using a new portable optical imaging system developed in Boppart’s lab.

Implantable device aids weight loss

More than 700 million adults and children worldwide are obese, according to a 2017 study that called the growing number and weight-related health problems a “rising pandemic.
New battery-free, easily implantable weight-loss devices developed by engineers at the University of Wisconsin–Madison could offer a promising new weapon for battling the bulge. 

Academic takes aim at plastics use in medtech

Dr Simon Werrett, a science historian and professor at University College London has researched the use of plastic in the medical industry and how it may be reduced.

We would like to wish you a merry Christmas!

On behalf of the Medical Devices Community, we would like to wish you a merry Christmas!

Management of medical device files with ISO 13485:2016

Blog by S.M. Waqas Imam, Industrial Engineer, Certified Lead Auditor, Blog Writer and Ambassador of the Medical Devices Community

ISO Technical Committee (TC 210) mandates the requirements of medical device files in the latest version of ISO 13485:2016 in order to make a consistent work flow for manufacturers and suppliers in the medical devices industry.

Supply Chain: Systems and People

Blog by Marc Baggen, Supply Chain Consultant.

In my previous blog, I explained the importance of process understanding within your company. Supply chain has multiple processes as the base.

Trade Secrets

Blog written by Guy Breitenstein, Senior IP Attorney – Contracting, Trade Secrets and Data

One of the biggest challenges for companies in the medical devices industry is to protect their innovative work. These innovations relate to all aspects of medical devices, all the way from the chemistry to the device design to the software. Innovations are often the result of years of research and development and represent a significant investment.

By patients for patients

Interview with Geert Dewulf , The Vice President Sales of Andaman7

Currently, access to personal medical data from patients in the healthcare industry is difficult. Although it is accepted that the most accurate information is needed to help patients, to improve the quality of clinical trials or the production of new drugs, getting this information is becoming more and more difficult because of legitimate hurdles linked with privacy and GDPR.

Hospital Trust begins using virtual reality to treat visual vertigo

Sheffield Teaching Hospitals NHS Foundation Trust has installed a virtual reality computer gaming suite at the Royal Hallamshire Hospital and could be used in the home of the patients over time.

FDA proposes more transparent de novo pathway

The US Food and drug Administration (FDA) has proposed revisions to the de novo pathway in order to make medical device classification more efficient and transparent.

Human images from world’s first total-body scanner unveiled

EXPLORER, the world’s first medical imaging scanner that can capture a 3-D picture of the whole human body at once, has produced its first scans.

MRI scans show promise in predicting dementia

One day, MRI brain scans may help predict whether older people will develop dementia, new research suggests.

Medical device regulation: Is a national database the right solution to unsafe devices?

An investigation led by International Consortium of Investigative Journalists (ICIJ) has found that many patients could have been fitted with devices such as pacemakers and hip replacements that are unsafe due to weak medical device regulation.

From an ICU ventilator to fully automatic ventilation

Blog written by Dick van Ginkel, Technician

Over the years there have been multiple impacts on ICU ventilators, due to the development of automatisation. ICU ventilators are breathing machines meant to temporally take over the complete breathing of people or partly support the breathing process.

AI in Healthcare: 5 Real-World Examples

The examples of AI and its applications in healthcare potentially offer affordable healthcare, efficient clinical trials, improved success rates, and a better quality of life.

What does the Brexit draft agreement mean for medical devices

The UK government has released a draft agreement regarding the withdrawal of the UK from the European Union along with a joint statement and outline of a political declaration on the future relationship between the UK and the EU.

Digital Radiology Advantages

Digital radiography (DR) is increasingly used in radiology practice, as the trend towards paperless and filmless radiography advances. DR is based on the use of X-rays for data acquisition with direct or indirect conversion to electrical charge using various detection-charge conversion systems.

AI algorithm outperformed majority of Cardiologists

At the American Heart Association’s Scientific Sessions 2018, Eko, a cardiac monitoring company that combines non-invasive sensors with machine learning, presented a clinical study abstract revealing the first murmur detection algorithm to outperform the majority of participating cardiologists in a clinical study.

Unique brain activity pattern may help detect schizophrenia early

Neuroscientists at the Massachusetts Institute of Technology (MIT) have found a correlation between a brain activity pattern and the development of schizophrenia.

UK to open five new AI medical centres to boost disease diagnosis

The UK Government has announced plans to open five new centres of excellence focussed on the use of artificial intelligence (AI) for digital pathology and medical imaging.

Detecting E.coli Strains Using Molecular Electronics

Finding a fast and inexpensive way to detect specific strains of bacteria and viruses is critical to food safety, water quality, environmental protection and human health. However, current methods for detecting illness-causing strains of bacteria such as E. coli require either time-intensive biological cell cultures or DNA amplification approaches that rely on expensive laboratory equipment.

Quadriplegic Cruising

Blog by Jim Ryan – A Quadriplegic

This month my wife, my son Daniel and myself had the opportunity of a lifetime and enjoyed the 22-day Panama Canal cruise from Vancouver, BC, Canada to Fort Lauderdale, Florida. This is the culmination of one of my life long dreams.

A no-deal Brexit: What will it mean for the Medical Devices Industry?

The Home Affairs Sub-Committee of The Select Committee on the European Union met in the House of Lords today to discuss how the UK’s access to medicines and medical devices could be affected in the event of a no-deal Brexit.

Tiny, pain-free vaccinations: microneedles and nanoparticles

If it’s up to PhD student Guangsheng Du, patients don’t need to worry about big needles anymore. At the Leiden Academic Center for Drug Research (LACDR), he studied the use of microneedles and nanoparticles as a new vaccination system. ‘I want to create a more patient-friendly delivery method.’ He defends his PhD on 30 October.

UK researchers discover early detection of cancer approach

Researchers at Edinburgh University in the UK have discovered a new approach that leverages mathematical methods devised by Second World War codebreaker Alan Turing for detecting a variety of diseases, including cancer, in advance.

3D printed medical devices: a tough trial for regulation?

The use of 3D printing in the medical industry is revolutionary and has huge potential. However, it also causes many issues for regulating bodies as theoretically anyone with a 3D printer and a blueprint could print their own devices, not just registered companies.

Supply Chain: An easy job?

Blog by Marc Baggen

In the industry I sometimes hear people say: “Supply chain, that is easy. Do some planning and send out the goods to the customers.’’ Yes, this is a good starting point, but far from complete. In a modern supply chain there is much more, especially in the Medical Devices Industry.

Could AI ‘Audrey’ be the future first response assistant?

Imagine a first responder answering the call to a natural disaster, a house fire, or an active shooter incident where there may be multiple injuries and unknown casualties. The information the responder needs to fulfill the mission is immeasurable.

University of Bremen launches new study in Medical Computing

The Fraunhofer MEVIS Institute for Medical Image Computing – in short: Fraunhofer MEVIS – is one of the world’s leading research centers in digital medicine. In order to prepare computer science students for challenges in this area, the institute and the University of Bremen are now cooperating even more closely in teaching. This winter semester saw the introduction of a new study area called Medical Computing in the Faculty of Mathematics / Computer Science.

Do people fear smart devices for data hacks?

Recent research carried out by medical device developer and manufacturer Bespak, has suggested that data security concerns could be delaying a rollout of potentially lifesaving smart inhaler products. These smart inhaler products could be utilised by users and result in the prevention of around 800 asthma deaths a year in the UK alone.  

A look at technical advancements in the medical devices industry

We spoke to Peter Tacken, Supply Chain Manager at Bausch & Lomb, about the biggest technical advancements in Supply Chain development, how they currently are, and could possibly influence the medical devices industry in the future. These technological changes are also known as the fourth industrial revolution. We asked Peter about his thoughts and opinions on these changes, as well as their pros and cons.

RightEye Eye-Tracking System Receives FDA 510(k) Clearance

RightEye LLC, an award-winning health technology company that uses eye tracking to revolutionize patient care and improve vision performance, today announced that the company’s vision system has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The FDA has cleared the RightEye™ system for recording, viewing, and analyzing eye movements in support of identifying visual tracking impairment in patients.

Needle-Free Diabetes Care: 7 Devices that Painlessly Measure Blood Glucose

Will the daily routine of finger pricking to monitor blood glucose levels finally come to an end for the millions living with diabetes?

”My accident and my ceiling lift”

Blog by Jim Ryan, a quadriplegic

As I mentioned in my previous blog, I will talk about my accident, some about my recovery and I will start with the lift my health care workers use to move me from my wheelchair to my bed and back again.

New Study Finds Nanoparticles Show Promise in Therapy for Triple-Negative Breast Cancer

Approximately 10-20 percent of diagnosed breast cancers are found to be triple-negative, meaning the breast cancer cells test negative for estrogen and progesterone receptors as well as HER2 receptors, genes that can play a role in the development of breast cancer. Triple-negative breast cancer can be more aggressive and difficult to treat as the cancer cells do not respond to hormonal therapies or therapies that target HER2 receptors.

Boston Scientific’s Eluvia Peripheral Long Term Drug Eluting Stent FDA Approved

Boston Scientific won FDA regulatory approval to introduce the Eluvia drug-eluting vascular stent to the U.S. market. The device is the first peripheral stent to offer sustained release of an antiproliferative drug (paclitaxel) for as long as a full year. The drug prevents restenosis, a common condition caused by native tissue growing over the stent.

University of Glasgow unveils Star Trek-inspired diagnostic device

A Star Trek-inspired handheld device based on a silicon chip could help make rapid, sophisticated medical diagnostics more accessible to people around the world, scientists say.

This is why Quality Training is so important! 

Blog by Ruud Lans, Quality and Regulatory Affairs Consultant

In the world of Medical Devices, most people are familiair with quality assurance and the regulatory requirements. But not everyone is known with the ins and outs of quality assurance, and that is why Quality Training is important. Below you can find which quality topics are important and§ which techniques are useful for employers and employees.

Medtronic set to acquire Mazor Robotics

On September 20, Medtronic announced a definitive agreement to acquire Israel-based Mazor Robotics for $1.6bn, with the acquisition expected to close in Q3 of Medtronic’s FY2019. This deal is the culmination of a nearly two-and-a-half-year partnership for the two companies.

Google’s AI tool can determine lung cancer type from images

A new study by a New York University (NYU) School of Medicine research team has found that a type of artificial intelligence (AI) tool called Inception v3 from Google can determine lung cancer types by analysing images of tumours.

iPhone app to monitor blood pressure

A research team at Michigan State University (MSU) has developed a proof-of-concept iPhone app that can deliver accurate blood pressure readings.

Researchers develop new testing device to better diagnose dizziness

Half of over-65s suffer from dizziness and problems with balance. But some tests to identify the causes of such problems are painful and can risk hearing damage. Now, researchers from Chalmers University of Technology, Sweden, have developed a new testing device using bone conduction technology, that offers significant advantages over the current tests.

Louis Meessen: Steps and regulations to follow when releasing a medical device

August 2018, Louis Meessen, Project Manager product innovation hi-tech. In my role as Project Manager in product innovation, I had to follow the procedures as we had defined in our Product Creation Procedur to fulfil regulations needed for a medical device release.

How close are 3D printed organs to reality?

The financial year of 2017/18 saw the highest number of organs ever donated in the UK. However, as organ donation figures continue to rise so too does the demand for transplants. By 2020 a new opt-out system for organ donation could be put in place across England if parliament approves “Max’s Law”.

A Tiny Neural Implants Even Your Brain Can Love

At Draper, medical implants are slimming down and getting connected, too. Draper’s latest system is tiny in size, but is poised to make a big impact in treating disease through its networked abilities.

What is it like being a Quadriplegic?

My name is Jim Ryan, I am from Canada and I am a full quadriplegic. Many people suffer from quadriplegia which means the partial or complete paralysis of all four limbs. A lot of quadriplegics will be mistaken as paraplegics as they have enough upper body strength to push themselves in their wheelchair, feed themselves and get around on their own.

Inside Costa Rica’s super-sized medical device sector

In 2017, medical devices became Costa Rica’s top export, surpassing the agricultural sector for the first time in the country’s history. With more than 70 medical device companies operating in Costa Rica, how has this small nation managed to develop such a successful and fast-growing medical technology sector?

A novel approach to cardiac surgery

Second-year medical student Kevin Cyr is part of a team of Stanford researchers investigating new ways to survey electricity in the heart. The research has led to the development of cardiac surgical devices that could one day help patients who suffer from a common heart ailment. “I’m using 3D-printed tools to design cardiac-mapping catheters, devices used by surgeons to map the electrical activity of the heart and find disturbances,” says Cyr.

How to Manage Non-Conformances?

Blog by Ruud Lans, Quality and Regulatory Affairs Consultant
Almost every company will have to deal with non-conformances at one point, whether relatively minor or potentially major. In the Medical Devices Industry, these non-conformances can cause serious problems, and there for the way of handling such problems is important. Here are a few tips for dealing with them, or being proactive to mitigate them:

Facebook and NYU School of Medicine launch research collaboration to improve MRI

Facebook and NYU School of Medicine’s Department of Radiology are excited to announce fastMRI, a new collaborative research project that will investigate the use of artificial intelligence (AI) to make magnetic resonance imaging (MRI) scans up to 10 times faster. If this effort is successful, it will make MRI technology available to more people, expanding access to this key diagnostic tool.

Imaging technique can spot tuberculosis infection in an hour

A research team led by a Stanford University School of Medicine professor has developed an imaging technique that can diagnose live tuberculosis (TB) in an hour and help monitor the efficacy of treatments.

OHSU professor conducts clinical trial with artificial pancreas using Xeris’ liquid glucagon

Xeris Pharmaceuticals, Inc., a specialty pharmaceutical company leveraging its novel technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations, announced today that Jessica Castle, M.D., an associate professor of medicine in the OHSU School of Medicine and OHSU Harold Schnitzer Diabetes Health Center in Portland, Oregon, is conducting a clinical trial with a dual-hormone artificial pancreas using Xeris’ ready-to-use liquid glucagon to evaluate a new closed-loop algorithm.

Artificial Intelligence: The Game Changer of Medtech

The year 2018 has seen a good influx of innovative medical devices. Artificial intelligence (AI) serves as a critical component in most of these novel devices.

Clinical Innovations expands into China with new subsidiary

Clinical Innovations continued its march toward global expansion, launching a new subsidiary in Shanghai to grow the company’s presence in the Chinese labor and delivery market. 

Evidation raises $30M alongside launch of new big data platform

Health data company Evidation Health raised $30 million in a series C round, bringing its total funding to $61 million, alongside the launch of a new platform built to digest large-scale sensor and behavioral data from real-world settings.

Growing a surgical robot

Following the success of minimally invasive surgery (MIS) for a number of indications and surgical specialities, medical device companies have turned to surgical robotics as the next big innovation.

3D printing in the medical field: four major applications revolutionising the industry

3D printing has many functions in a variety of industries, however, in the medical field it has four main applications.

To incorporate wearable tech into total knee replacements

Johnson & Johnson’s DePuy Synthes is linking up with 360 Knee Systems, an Australian developer of digital solutions for personalizing total knee replacements, including the construction of 3D models for virtual surgery planning, wearable devices and mapping patients’ kinetic movement.

Radiation from CT scans can increase risk brain cancer

A study led by Netherlands Cancer Institute has revealed an increased risk of brain cancer in children that receive computed tomography (CT) head scans. High doses of ionising radiation are emitted during a CT scan, which may cause the DNA mutations that lead to cancer.

Senseonics’ recently approved implantable glucose monitor wins real-world accuracy study

A three-way comparison of continuous glucose monitoring devices found that Senseonics’ recently approved Eversense implantable monitor was significantly more accurate than the Dexcom G5 and the Abbott Freestyle Libre Pro.

Thermo Fisher Scientific to buy Gatan for $925m

Diagnostic products maker Thermo Fisher Scientific has signed a definitive agreement to acquire software developer Roper Technologies’ wholly owned subsidiary Gatan for about $925m.

HKBU unveils new device to enable safe growth of neural stem cells

Researchers from Hong Kong Baptist University (HKBU) have developed a device containing a specific nanotechnology layer to enable the in vitro proliferation of neural stem cells(NSCs). The research team was jointly led by Department of Biology professor Ken Yung Kin-lam and Department of Physics associate professor Dr Jeffery Huang Zhifeng.

‘Smart stent’ detects narrowing of arteries

A research team from the University of British Columbia (UBC) in Vancouver, Canada has developed a ‘smart stent’ that can monitor even subtle changes in the blood flow of arteries, allowing the detection of narrowing in its earliest stages and making early diagnosis and treatment possible.

This robot is able to perform surgery

This robot, created by researchers at the Max Planck Intitute, is able to perform surgery. Isn’t medical technology amazing?

Imaging method reveals effects of treatment for mutant IDH1 gliomas

Researchers at Massachusetts General Hospital (MGH) in the US have used magnetic resonance spectroscopy (MRS) imaging to investigate the mechanisms behind a potential targeted treatment for gliomas.

Algorithm creates reliable sensory feedback for prosthetic arm users

Researchers at the University of Illinois have developed a control algorithm that regulates current so that prosthetic arm users can feel a steady sensation of touch, even if electrodes begin to peel off or sweat builds up.

Classification of Medical Devices

A medical device is designed to contribute on improving patient’s health through diagnosis, therapy or surgery which are monitored and under strict regulations by the Food and Drug Administration (FDA). The FDA has established the classification of medical devices for 1700 different generic types of devices within its industry. How are these types of devices classified, and which devices belongs to what class? The classification of medical devices is explained in this article.

Starting your R&D project

R&D in the medical industry is one of the most, if not the most, important things. With the world being as innovative as it is right now, it is no strange thing that R&D spendings within the medical industry are rising. Not only the big corporations are accountable for this rise in spendings, more and more startups are trying to enter the market. Entering this market can be tricky for startups, especially with all the regulations and the high costs of research and development. A good preparation for starting your R&D project is key, and a few points are mentioned below that can help you with process.

The Medical Devices Regulation in Europe

In 2008, a conference was initiated by the European Commission on the medical devices regulation, which resulted in more than 200 remarks and suggestions for revision of the regulation. Therefore, the European Commission proposed a plan in 2012, of revising the medical devices regulation framework, where the existing directives were going to be replaced.
Read here what these modifications consist of.

The Future of Medical Devices

With the world becoming more and more technological every day, the medical device industry cannot stay behind. And luckily, it doesn’t. The possibilities are endless, and below you can find five technological innovations that could play a massive part of the future of medical devices.

Working in the Research & Development sector

We had an interview with Luke D. Burke, PhD- Senior Research and Development Engineer, about his experiences within the medical devices industry.

Everything must be better, safer and more sustainable

Blog by Bert van Boxtel – QA Consultant

During the 80’s, I joined the medical devices industry as a young guy. I chose to work with medical techniques because of idealistic reasons: by creating medical devices I am helping to create a better world. That idea suited me much more than creating luxury products for our consuming behaviour.

The revision of Medical Devices Regulation in Europe

From pregnancy tests and HIV blood tests to contact lenses and machines in optometry to breast implants and hip replacements. Medical devices include a wide range of products used by patients and doctors. Medical devices are necessary to our health and quality of life. In May 2017, the European Commission decided to do a revision on the medical devices regulation due to an incident that have taken place, and wrong interpretations of these regulations. Read here why this is important.

10 Groundbreaking Medical Technology Inventions

Nowadays, we consider most of the medical technology as normal. However, throughout the history of mankind these devices were invented, and these should still be seen as extremely special. These medical devices are still saving lives and making day-to-day life for many people a lot easier. Here are 10 historical inventions that are worth mentioning.

Functional connectivity MRI could help detect brain disorders and diseases

There are no laboratory tests to diagnose migraines, depression, bipolar disorder and many other ailments of the brain. Doctors typically gauge such illnesses based on self-reported symptoms and behavior.

Will medtech drive the next Southeastern U.S. industrial revolution?

One South Carolina startup relies on the Southeastern U.S. history of engineering innovation, new infrastructure and quality of life to drive drug delivery innovation through nanoparticles.

Wearable system continuously monitors stomach activity

California researchers have created an electrocardiogram-like system for the gastrointestinal tract that monitors electrical activity in the stomach over a 24-hour period.

The system is a wearable, non-invasive system that provides GI activity monitoring outside of clinical settings while increasing the chance of identifying abnormal activity. It is a 3D printed portable box that is connected to 10 small wearable electrodes.

Why medtech needs innovations in the law department to protect intellectual property

Here’s the scenario: after investing millions of dollars and years of resources in R&D, your company has received approval to market your cutting-edge medical device. If your flagship device does not establish a strong foothold on the market, the enterprise will likely be doomed and your investors will lose most, if not all, of their capital.

FDA grants clearance for first contact lens with light-adaptive technology

The U.S. Food and Drug Administration today cleared the first contact lens to incorporate an additive that automatically darkens the lens when exposed to bright light. The Acuvue Oasys Contact Lenses with Transitions Light Intelligent Technology are soft contact lenses indicated for daily use to correct the vision of people with non-diseased eyes who are nearsighted (myopia) or farsighted (hyperopia).

Why partnerships between medtech companies and doctors are so important

As new devices and technologies are being developed in the medtech industry, doctors and physicians have to learn about the devices on platforms that are different from what they know. One way to help make the healthcare provider’s transition into using new devices easier is to forge a partnership between the industry and the physician, according to Laura Dietch, CEO of BioTrace Medical(Menlo Park, Calif.).

This visor-like device could be a defibrillator for stroke

A portable, visor-like device has shown potential for detecting emergent large-vessel occlusion with 92% accuracy in patients who may have had a stroke. The researchers suggest that the diagnostic device could be readily accessible to emergency personnel and in public spaces in the same way a defibrillator is available for treating heart attacks.

Study: Laser lead extraction may raise mortality rate

Laser-based extraction of pacemaker or defibrillator leads could pose a higher risk of death than cutting sheath systems, according to a new meta-analysis study reported by Medscape. In the analysis, researchers found a ninefold increase in mortality associated with the procedures when they were performed using a popular excimer laser lead-extraction sheath when compared against sheaths that use a metal blade.

German team develops new blood test for Alzheimer’s diagnosis

Researchers from Ruhr University Bochum in Germany have developed a new blood test that can identify indicators of Alzheimer’s disease much earlier than the appearance of initial symptoms.Published in EMBO Molecular Medicine, the results of the research indicated a potential to detect at-risk individuals and allow new drug discovery opportunities.

Wheelchair of the future

Published by www.cheddar.com 

Researchers propose new approach to look deeper into brain function

To uncover connections between brain regions and specific cognitive functions, neuroscientists have long made extensive use of techniques like functional resonance imaging (fMRI). First introduced in the 1990’s, the method allows tracking the brain’s activity while a test subject performs a task or responds to stimuli in the MRI scanner.

FDA releases top 3 medical device regulation goals

FDA medical device regulators’ top priorities over the next three years include improving employee engagement, increasing simplicity and building collaborative communities, according to a new Strategic Priorities paper that FDA’s CDRH released today. The agency said the priorities further its overall goal of providing Americans with more timely access to the latest high-quality, safe and effective medical devices.

Artificially-produced diamonds could improve brain imaging

Researchers have optimised the design of laboratory-grown artificial diamonds for use in biosensing applications such as magnetic brain imaging.In ‘Designing Diamonds for Medical Imaging Technologies’, published in Applied Physics Letters, the researchers from Osaka University, the Tokyo University of Science, the Tokyo Institute of Technology and Kyoto University reported they have developed diamonds with nitrogen-vacancy (NV) centres that can detect changes in magnetic fields.

Home genetic tests may have negative implications finds study

Widespread access to personal genetic interpretation tools has potentially negative implications on users’ understanding of their health, according to a new study by Boston University School of Public Health. The study is the first to examine the challenges that can arise when consumers contact healthcare providers because they have concerns about their DNA interpretation results.

Taxes on Pacemakers, Medical Devices Returning in 2018

Expect high acquisitions, possible bidding wars in 2018

Look for another strong year for medtech acquisitions in 2018 — and even potential bidding wars — predicts patent attorney David Dykeman.The wave of mergers and acquisitions in the medical device industry should continue this year, both in terms of value and volume, according to patent attorney David Dykeman.

New 3D tissue model of developing heart could be used to test safety of drugs during pregnancy

The heart is the first organ to develop in the womb and the first cause of concern for many parents.
For expecting mothers, the excitement of pregnancy is often offset by anxiety over medication they require. Parents and doctors often have to consider the mother’s health as well as the potential risk regarding how medication could affect their baby. 

Traumatic brain injury associated with higher risk of dementia

The risk of dementia, including Alzheimer’s, was significantly higher in people who had experienced a traumatic brain injury (TBI) than with people who had no history of TBI, according to one of the largest studies to date on that association.Findings from a review of nearly 2.8 million patient cases in Denmark were published April 10 in The Lancet Psychiatry.