IDE supplement approved by FDA
28 April 2022
Virtual Incision announced today that it received an FDA investigational device exemption (IDE) supplement for its MIRA platform.
Lincoln, Nebraska-based Virtual Incision’s IDE supplement allows the company to complete the final stage of its clinical study for the MIRA (miniaturised in vivo robotic assistant) platform in bowel resection procedures.
The company said in a news release that the FDA granted the IDE supplement following the reporting of favourable interim clinical study results on the safety profile of the MIRA surgical robotic platform. Results of the completed study following the supplemental approval will support the company’s upcoming FDA de novo application for marketing authorization for the MIRA platform.
MIRA received IDE approval in October 2020. In November 2021, Virtual Incision completed a $46 million Series C financing round to support the robotic surgery platform.
Dr. Michael Jobst and Dr. Kelly Krier of the Bryan Medical Center in Lincoln, Nebraska, as well as Dr. John Marks and Dr. Henry Schoonyoung of the Lankenau Medical Center in Wynnewood, Pennsylvania, completed the first cases of the study for MIRA.
Jobst said in the release that the clinical experience with MIRA has been “extremely positive” to date, while he also emphasised that the platform’s “accessibility and efficiency” could bring exciting benefits to patients.
“MIRA was created to address the limitations of traditional robotic-assisted mainframe machines. We miniaturised and simplified MIRA to make it more accessible, easy to use, and easy to adopt,” Virtual Incision President and CEO John Murphy said in the release. “These are the features that will allow surgeons to treat more patients each day. It is encouraging to see MIRA demonstrating the potential to help surgeons perform simplified robotic procedures safely and precisely.
“Completing the final stage of our clinical study will be a key milestone along MIRA’s regulatory pathway, and we will continue to focus on clinical excellence to best support the innovation we provide to patients and surgeons.”
Following the supplemental approval, the results of the completed study will be used to support the company’s planned FDA de novo application for marketing authorization for the MIRA platform. Need assistance looking for professionals to help your Medical Devices company reach its full potential? Check out how we can help you with that and discover why our service is right for you here!
Also published on Massdevice.com