The FDA Breakthrough Devices Program is intended to help patients receive more timely access to breakthrough technologies that have the potential to provide more effective treatment. Under the program, the FDA provides priority review and interactive communication regarding device development and clinical trial protocols, through to commercialization decisions.
"We are the first surgical robot to be recognized with the FDA's Breakthrough classification," said Adam Sachs, CEO and Co-Founder of Vicarious Surgical. "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 commercialization."
Additionally, Vicarious Surgical has appointed Scott Huennekens, a proven leader in the medical device industry, to its Board of Directors. He most recently served as the president & CEO of Verb Surgical, a Google and J&J joint venture, and was previously president & CEO at Volcano Therapeutics and Digirad Corporation. Huennekens holds an MBA from Harvard University and a B.S. in business administration from the University of Southern California.
Sachs stated, "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 organizational growth. We are thrilled to have Scott join our Board of Directors."
"I am honored to join Vicarious Surgical's Board of Directors," said Huennekens. "Vicarious Surgical has developed the most innovative robotic technology I have seen, and I believe it will transform the future of minimally invasive surgery."