FDA has granted breakthrough device status to Vicarious Surgical's robotic surgical system, the company said Wednesday. The status, which Vicarious says is the first awarded to a surgical robot, covers technology designed to "shrink the surgeon and put them inside the patient."
The company's goal is to enable surgeons to perform surgery through "a single micro-incision." Vicarious is trying to achieve this through the use of miniaturized robotics.
Vicarious disclosed the breakthrough status alongside news that Scott Huennekens, the former CEO of Google and Johnson & Johnson’s robotic surgery joint venture, joined its board of directors.
Vicarious first made headlines last year when it raised almost $17 million in a round led by Khosla Ventures and Innovation Endeavors, a venture capital fund set up by the former CEO of Google. Funds associated with the founders of Microsoft, Salesforce and Yahoo also contributed money.
Subsequent financing rounds have brought Vicarious' total funding up to around $30 million, setting it up to develop a commercial product. Yet few public details are known about its technology.
Instead, Vicarious has spoken in broad terms about its approach. The goal is to enable surgeons to perform surgery through "a single micro-incision." Vicarious is trying to achieve this through the use of miniaturized robotics.
The company is pairing its miniaturized robotics with virtual reality technology. In theory, the combination could enable surgeons to see and act as if they were in the body, leading Vicarious to claim it has effectively shrunk "the surgeon and put them inside the patient."
More details of how that will work in practice should emerge as Vicarious gets closer to market. There are signs Vicarious is now entering that stage of its evolution. In February, Vicarious said a $10 million financing would "drive development of a commercial product."
The breakthrough status provides further evidence that Vicarious is gearing up to bring its product to market. Through the breakthrough program, Vicarious will benefit from extra input from FDA, a speedy regulatory review and potentially an easier reimbursement pathway.
As it works to bring its device to market, Vicarious will also benefit from the input of Huennekens, who has joined its board of directors. Huennekens was the founding CEO of Verb Surgical, a joint venture set up by Google and J&J to digitize and robotize surgery.
Verb and Vicarious both aim to disrupt a market that has long been dominated by Intuitive Surgical. A growing number of other companies, including CMR Surgical, J&J and Medtronic, have similar aspirations.