BOSTON — Vicarious Surgical Inc. today announced that the U.S. Food and Drug Administration has granted it Breakthrough Device Designation, the first surgical robot to be so recognized. The company also appointed industry veteran Scott Huennekens to its board of directors.
Vicarious Surgical was founded in 2014 and is applying innovations in robotics and virtual reality to minimally invasive surgery. The company is led by an experienced team of technologists, medical device professionals and physicians. Vicarious Surgical raised $10 million in January, and its backers include Bill Gates, Khosla Ventures, Eric Schmidt’s Innovation Endeavors, Jerry Yang’s AME Cloud Ventures, and Marc Benioff.
The Breakthrough Devices Program is intended to help patients receive more timely access to breakthrough technologies that could 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,” stated Adam Sachs, co-founder and CEO 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.”
Vicarious Surgical appoints Huennekens
Huennekens, who is joining Vicarious Surgical’s board, most recently served as president and CEO of Verb Surgical, a joint venture of Google parent Alphabet Inc. and Johnson & Johnson. He was previously president and CEO at Volcano Therapeutics and Digirad Corp. Huennekens holds an MBA from Harvard University and a B.S. in business administration from the University of Southern California.
“Scott has keen business insight into the complex surgical robotics market and brings a wealth of experience from the broader medical device industry,” said Sachs. “Vicarious Surgical will benefit greatly from his involvement as we continue with fundraising, product development and organizational growth.”
“I am honored to join Vicarious Surgical’s board of directors,” Huennekens said. “Vicarious Surgical has developed the most innovative robotic technology I have seen, and I believe it will transform the future of minimally invasive surgery.”