Robotic Surgery Startups Make Strides Towards FDA Approval

Vicarious Surgical and SS Innovations, two emerging players in the robotic surgery market, have announced significant progress in their efforts to bring innovative surgical systems to the U.S. market. These developments signal intensifying competition in a field long dominated by Intuitive Surgical.

Vicarious Surgical Partners with UMass Memorial Medical Center

Vicarious Surgical has signed an agreement with UMass Memorial Medical Center, the flagship hospital of the UMass Memorial Health system, to promote adoption of its robotic surgery system. The collaboration aims to improve patient outcomes, enhance surgeon education, and streamline inventory management and sterilization protocols.

Key aspects of the partnership include:

• Standardization of pre-procedure processes and post-procedure care
• Case observation for surgeons
• System testing of the Vicarious robot
• Sharing research insights and peer-to-peer education

Dr. John Kelly, chief of general and minimally invasive surgery at UMass Memorial, emphasized that the program supports the organization's efforts to improve surgical outcomes and care delivery.

Vicarious Surgical expects to begin treating its first clinical patients this year and plans to submit a request for de novo classification to the Food and Drug Administration (FDA) in late 2026. The company is initially seeking FDA clearance for its single-port system in ventral hernia procedures.

In its recent financial report, Vicarious Surgical disclosed a net loss of $15.4 million for the first quarter, compared to a $17 million loss in the same period last year. The company had $37.4 million in cash and investments as of March 31 and projects a full-year cash burn of approximately $50 million.

SS Innovations Prepares for FDA Submission

SS Innovations has announced plans to submit a de novo classification request for its SSi Mantra 3 surgical robotic system to the FDA in July. The company is seeking indications in urology, gynecology, general surgery, and thoracic and cardiac surgery.

Already operational in six countries, SS Innovations has installed 80 SSi Mantra robots in 75 hospitals, with over 3,800 surgeries performed to date. The company launched its latest version, the SSi Mantra 3, in June 2024 and is currently pursuing CE mark approval for the European market.

SS Innovations, which went public on the Nasdaq in April, recently reported expected first-quarter revenue of approximately $6.4 million with a gross margin of about 45%.

These developments from Vicarious Surgical and SS Innovations underscore the growing competition in the robotic surgery market, as new entrants seek to challenge established players and expand the adoption of minimally invasive surgical techniques.