SS Innovations submits response to FDA information request on SSi Mantra 510(k) filing

SS Innovations submitted its response to an FDA request for additional information on its 510(k) filing for the SSi Mantra. The package includes final data from expanded human clinical and human factors validation work, plus a bridging study completed in August 2026. FDA review of the response and the 510(k) is expected to conclude in Q1 2027 for an initial cholecystectomy indication. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. SS Innovations International Inc. published the original content used to generate this news brief via (Ref. ID: 202610130830PRIMZONEFULLFEED9844239) on October 13, 2026, and is solely responsible for the information contained therein. (C)