Boston-based Vicarious Surgical has received US Food and Drug Administration (FDA) breakthrough status for its virtual reality (VR)-managed robotics platform.
➨ The ‘breakthrough device’ designation provides priority review and interactive communication
➨ Vicarious Surgical’s VR-managed robotics platform is aimed at minimally invasive surgery
➨ The company has also appointed Scott Huennekens to its board of directors
The ‘breakthrough device’ designation, through which the FDA provides priority review and interactive communication on device development and clinical trial protocols all the way to commercialisation decisions, gives Vicarious Surgical a regulatory pathway toward approval for its VR-managed robotics platform, which the company has been working on since 2014.
Adam Sachs, chief executive officer and co-founder of Vicarious Surgical, commented: “We are the first surgical robot to be recognised with the FDA’s ‘Breakthrough’ classification. This validates the platform we are developing and the clinical value it can offer surgeons and patients. It also adds to our momentum as we advance our innovative technology toward commercialisation.”
Vicarious Surgical, whose robotics platform is geared toward minimally invasive surgical treatment and counts Bill Gates, Khosla Ventures, Eric Schmidt’s Innovation Endeavors, Jerry Yang’s AME Cloud Ventures and Marc Benioff among its backers and investors, has also appointed Scott Huennekens to its board of directors.
Medical device industry expert Huennekens most recently served as president and chief executive officer of Verb Surgical, a Google and J&J joint venture, and previously held the same roles at Volcano Therapeutics and Digirad Corporation.
Sachs said of the appointment of Huennekens: “Scott has keen business insight into the complex surgical robotics market and brings a wealth of experience from the broader medical device industry. Vicarious Surgical will benefit greatly from his involvement as we continue with fundraising, product development and organisational growth. We are thrilled to have Scott join our board of directors.”
Huennekens added: “I am honored to join Vicarious Surgical’s board of directors. Vicarious Surgical has developed the most innovative robotic technology I have seen, and I believe it will transform the future of minimally invasive surgery.”
Image credit: Vicarious Surgical