Neural signal software receives CE mark as Class I medical device

12 October 2021


software

The Wyss Center has received the CE mark Class I medical device for its Epios Cloud software. Epios Cloud is a web-based application for the online storage, processing, and review of neural signals, including the ultra-long-term data recorded by an emerging generation of devices for remote brain monitoring.

Its features allow navigation of datasets covering months and years while access through a web browser allows clinicians to access patient data anywhere and anytime.

With the flexibility to connect to brain – or other bio-signal – recording devices over the web, Epios Cloud provides insights on multiple long-term data sources enabling clinicians to develop bespoke analytics to support personalised clinical decision making.

Clinicians are increasingly seeking options for outpatient neural monitoring over weeks to months. In epilepsy, home-based monitoring of brain activity during everyday life will help characterise the type and number of seizures, improve diagnosis and pre-surgical planning, and help build personalised treatment plans.

Aleksander Sobolewski, Wyss Center neuroscientist, said: “We developed Epios Cloud as we needed software that would track not only when seizures occur but also the biosignals linked to epilepsy events. Epios Cloud allows us to synchronise neural data with heart rate or movement information over months or years. It gives us a glimpse of what is really going on in the brain during everyday life. In the future, additional data streams could easily be integrated into the platform to support other clinical applications. Importantly, centralised data storage will allow a fundamental change in automated analysis of neural data, allowing artificial intelligence algorithms to learn on an ever-growing global data lake – the development of which is already underway.”

While current electroencephalogram (EEG) software is primarily optimised for the review of neural recordings that last minutes to hours, Epios Cloud is poised for the transition to longer-term recordings of weeks to months. Clinicians can also annotate the data with real-life events and develop novel analytics to automatically present regions of interest to complement visual screening.

George Kouvas, MBA, Wyss Center’s chief technology officer, said: “Epios Cloud is set to reveal new insights about epilepsy in individual patients – paving the way for personalised therapies. Now that Epios Cloud is CE marked, we look forward to connecting it to more brain recording modalities and to bringing this innovative long-term brain monitoring platform to more clinical or outpatient settings across Europe and beyond. Epios Cloud also has potential for use in stroke rehabilitation as well as neuromodulation of brain circuits for mental health applications.”

Epios Cloud is medical device software of Safety Class A as per IEC 62304 and CE-marked as Class I as per the Medical Device Directive 93/42/EEC. Epios Cloud is intended for displaying and reviewing electroencephalogram (EEG) recordings made by EEG devices using scalp and sub-scalp electrodes, heart rate and accelerometer measurements. The device is intended to be used by qualified medical practitioners. CE marking indicates that a product has been assessed and deemed to meet European Union safety, health and environmental protection requirements.

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Also published on Med-technews.com