SS Innovations is preparing to submit a De Novo Classification Request to the U.S. FDA in July 2025 for its SSi Mantra 3 surgical robotic system. If approved, it would enable the company to market the technology in the U.S. across multiple surgical specialties. The request follows extensive clinical use, with over 750 procedures already performed using the latest system version since its 2024 launch.

The system has been installed in 37 locations and has shown positive safety and efficacy results, including in cardiac surgeries, with no device-related complications reported. Clinical data has been validated by a leading third-party contract research organization (CRO), strengthening the FDA application.

The SSi Mantra 3 is already approved in six countries, and SS Innovations is also pursuing CE Mark approval in the EU. The company aims to provide an affordable and accessible robotic surgery platform globally, with a growing presence in both developed and emerging markets.

Medtech Spectrum's Summary:

• SSi Mantra 3 targets FDA De Novo clearance for multiple surgical indications.

• Over 750 real-world surgeries show no device-related complications.

• Part of global push for cost-effective robotic surgery access.