SS Innovations submits FDA response with final data from expanded SSi Mantra clinical, human factors study

SS Innovations submitted its response on Oct. 5, 2026 to an FDA request tied to its SSi Mantra 510(k) filing. Results have already been provided to the FDA, including final data from an expanded human clinical and human-factors validation study. The submission also included final data from a bridging study completed in August 2026 in Colombia. The studies were intended to support the system’s safety and feasibility case for an initial U.S. indication in gallbladder removal. FDA review of the response and the 510(k) is expected to conclude in the first quarter of 2027. 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 EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001213900-26-108792), on October 13, 2026, and is solely responsible for the i