SS Innovations Says it Completed a Human Factors Validation Study for SSi Mantra Surgical Robotic System in September
MT Newswires Live
Oct 02
SS Innovations International (SSII) said Thursday it completed a human factors validation study for its SSi Mantra surgical robotic system at Johns Hopkins Hospital in September.
The purpose of the study was to provide evidence the SSi Mantra meets the US Food and Drug Administration's requirements for usability and patient safety, the company said.
The company said it expects to submit a 510(k) premarket notification to the FDA for SSi Mantra in Q4.
The company said it could receive FDA clearance to market SSi Mantra in H1 2026, based on standard review timelines.
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