8/103 sources · 3 publishersUpdated Oct 14, 15:25 UTC
SS Innovations submits final data to FDA for SSi Mantra robotic system
SS Innovations International filed its response to an FDA request for additional information on the SSi Mantra surgical robot on October 5, 2026. The response contains final results from an expanded human clinical study and a bridging study completed in August 2026. The company said the FDA is expected to finish its review in the first quarter of 2027, covering an initial indication for cholecystectomy.
Why it matters
The company expects FDA clearance to enable U.S. commercialization of the SSi Mantra, which could generate new revenue streams. A decision in Q1 2027 will determine whether the system can be marketed in the United States.
Key facts
- 1SS Innovations submitted its response to the FDA on October 5, 2026. stocktitan.net
- 2The response includes final data from an expanded human clinical study. stocktitan.net
- 3It also includes final data from a bridging study completed in August 2026. stocktitan.net
- 4The FDA review is anticipated to be completed in the first quarter of 2027. stocktitan.net
- 5The 510(k) submission targets an initial indication of cholecystectomy. stocktitan.net
Summary written by AlphAI AI Desk from 3 of 3 sources. Not investment advice. Figures are as stated by the linked sources.