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SS Innovations Submits 510(k) Premarket Notification to the FDA for the Company’s SSi Mantra Surgical Robotic System
-- Submission covers multiple indications including general, urological, colorectal, gynecological and cardiac surgeries -- FORT LAUDERDALE, Fla., Dec. 08,
About this update from Ss Innovations International Inc.
[{"type":"text","content":"-- Submission covers multiple indications including general, urological, colorectal, gynecological and cardiac surgeries -- FORT LAUDERDALE, Fla., Dec. 08, 2025 (GLOBE NEWSWIRE) -- SS Innovations International, Inc. (the “Company” or “SS Innovations”) (Nasdaq: SSII), a developer of innovative surgical robotic technologies dedicated to making robotic surgery affordable and accessible to a global population, today announced that the Company submitted a 510(k) premarket notification to the United States Food and Drug Administration (the “FDA”) on December 5, 2025, for the SSi Mantra surgical robotic system for multiple specialty procedure types, including: general, urological, colorectal, gynecological, and cardiac surgery. Dr. Sudhir Srivastava, Chairman of the Board and Chief Executive Officer of SS Innovations, commented, “Our submission of a 510(k) premarket notification to the FDA marks an important milestone in our strategic plan to introduce the Company’s advanced, cost-efficient SSi Mantra surgical robotic system to the U.S. market. Given its affordability, differentiated technology, and proven performance across our existing global installations, we believe the SSi Mantra represents a highly compelling option for hospitals and surgeons in the United States, especially those serving underserved patient communities.” Based on a pre-submission meeting and subsequent discussions with the FDA, the Company decided to pursue a 510(k) submission, rather than a De Novo request for the SSi Mantra surgical robotic system, aiming to benefit from the pathway’s potential speed and cost efficiencies. The FDA has stated that its goal is to complete reviews of 510(k) submissions within 90 days of receipt. However, time to approval could be longer due to factors such as the 15-day acceptance review, the submission of additional information, and a submitter's response time. Separately, the Company continues along the pathway towards a European Union CE marking certification for the SSi Mantra that it believes it could obtain in the first half of 2026. As of November 30, 2025, the SSi Mantra cumulative installed base totaled 138 systems across eight countries where the Company’s surgical robotic system has received regulatory approval. To date, 137 hospitals have installed the SSi Mantra and over 7,300 surgical procedures have been performed,...