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SS Innovations to submit SSi Mantra 3 to FDA in July

  • SS Innovations plans to submit a de novo classification request to the U.S. FDA for its SSi Mantra 3 surgical robotic system in July, featuring 40+ robotic surgical instruments for various specialties.
  • The SSi Mantra 3 system offers a modular, open-console design with 3D visualization, integrated machine learning models, and has been used in over 3,800 surgeries, including cardiac cases.
  • Real-world clinical data supports the safety and efficacy of the SSi Mantra 3 system for a wide range of surgical procedures, with plans for global expansion and FDA application in progress.
  • SS Innovations aims to democratize access to healthcare with its cost-effective SSI Mantra 3 robotic system, which has received regulatory approval for remote surgery and teleproctoring.

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