SS Innovations Completes Human Factors Study

By Bobby Samwell • Friday, October 03 10:26 • Permanent Link

SS Innovations International, Inc. (NASDAQ: SSII) has announced a significant milestone in its regulatory progress for the SSI Mantra surgical robotic system. The company successfully completed a human factors validation study for the SSI Mantra at Johns Hopkins Hospital in September 2025 and anticipates submitting a 510(k) premarket notification to the FDA for multiple specialty indications in the fourth quarter of 2025.

The completion of the human factors validation study marks a crucial step for SS Innovations, as it provides essential evidence that the SSI Mantra meets the FDA’s requirements for usability and patient safety. The company has engaged RQM+, a leading medtech-focused CRO, to assist with the 510(k) submission. If the FDA determines that the SSI Mantra can be marketed in the United States, SS Innovations believes that clearance could occur in the first half of 2026 based on standard review timelines.

Dr. Sudhir Srivastava, Chairman of the Board and CEO of SS Innovations, highlighted the company's pivot from filing a de novo request to pursuing the 510(k) regulatory pathway, citing potential speed and cost advantages. The recent completion of the human factors validation study at Johns Hopkins Hospital is a significant development in bringing the advanced and cost-efficient SSI Mantra surgical robotic system to the U.S. market.

As of September 30th, 2025, the SSI Mantra cumulative installed base totaled 125 across six countries where the company’s surgical robotic system has received regulatory approval. Additionally, 119 hospitals have installed the SSI Mantra, and over 6,000 surgical procedures have been performed, including 60 telesurgeries and 310 cardiac procedures.

SS Innovations International, Inc. (NASDAQ: SSII) aims to make the benefits of robotic surgery affordable and accessible to a larger segment of the global population. The company's product range includes its proprietary "SSI Mantra" surgical robotic system and its comprehensive suite of "SSI Mudra" surgical instruments, which support a variety of surgical procedures, including robotic cardiac surgery. The market has reacted to these announcements by moving the company's shares -8.59% to a price of $6.49. Check out the company's full 8-K submission here.

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