Vicarious Surgical signed an agreement with UMass Memorial Medical Center, the UMass Memorial Health system’s flagship hospital, to promote adoption of its robotic surgery system.
Vicarious expects to begin treating its first clinical patients this year and submit a request for de novo classification to the Food and Drug Administration in late 2026.
The collaboration with UMass robotic surgeons and staff will focus on practices for improving patient outcomes after surgery, surgeon education, streamlining inventory management and sterilization protocols.
Standardization of pre-procedure processes and post-procedure care, case observation for surgeons and system testing of the Vicarious robot will be included. Sharing research insights and peer-to-peer education are also planned.
John Kelly, chief of general and minimally invasive surgery at UMass Memorial, said the program supports the organization’s efforts to improve surgical outcomes and care delivery.
Vicarious on Monday also reported first-quarter financial results that included a net loss of $15.4 million, compared to a net loss of $17 million in the year-ago period. The robot developer had $37.4 million of cash and investments as of March 31 and expects a full-year cash burn of about $50 million.
Vicarious has said it will seek FDA clearance for its single-port system in ventral hernia procedures as its first indication.
SS Innovations nearing FDA submission
SS Innovations plans to submit a de novo classification request for its SSi Mantra 3 surgical robotic system to the FDA in July.
The company said Thursday it plans to apply for indications in urology, gynecology, general surgery, and thoracic and cardiac surgery in its FDA submission.
SS Innovations already sells its robot in six countries and is pursuing CE mark approval for Europe. The company has installed 80 SSi Mantra robots in 75 hospitals, with more than 3,800 surgeries performed. The SSi Mantra 3 version was launched in June 2024.
The company, whose shares began trading on the Nasdaq market in April, last week said it expects to report first-quarter revenue of about $6.4 million and a gross margin of about 45%.
