SS Innovations International Inc (SSII) News & EventsSSIISS Innovations International Inc

SS Innovations Submits Response to FDA Additional Information Request

SS Innovations announced that the company submitted its response to a request for additional information letter received from the FDA with regard to the company's 510 submission for its SSi Mantra surgical robotic system. The company's response to the AINN includes final data from an expanded human clinical and human factors validation study for the SSi Mantra. The completion of the Study was designed to provide essential evidence that the SSi Mantra meets the FDA's requirements for safety, efficacy and feasibility, and is an important part of the company's 510 premarket notification. The company's response to the AINN also includes final data from a bridging study, which the company completed in August at Hospital Internacional de Colombia, a member of the Mayo Clinic Care Network located in Bucaramanga, Colombia. The company anticipates that the FDA will complete its review of the company's AINN response and the company's 510 submission for the SSi Mantra in the first quarter of 2027.

SS Innovations Appoints Sarah Romano as CFO

SS Innovations (SSII) announced the appointment of Sarah Romano as CFO, effective August 3. Romano will be based in the United States. Most recently, Romano served as CFO of Vicarious Surgical (RBOT).

SS Innovations Surpasses 10,500 Cumulative Surgeries

SS Innovations announced that more than 10,500 cumulative surgeries have been successfully performed with the company's SSi Mantra surgical robotic system. As of April 30, the cumulative number of multi-specialty procedures completed with the SSi Mantra exceeded 10,500, including more than 500 cardiac procedures, 170 telesurgeries, and 125 pediatric surgeries. Additionally, approximately 2,100 physicians have been trained on the SSi Mantra, which has been utilized to perform over 170 different types of procedures.