SS Innovations begins regulatory submissions for surgical robot

August 2, 2023 By Sean Whooley

SS Innovations announced today that it commenced the process of applying for regulatory approvals for its surgical robot device.

Fort Lauderdale, Florida-based SS Innovations plans to apply for FDA approval and CE mark for its flagship SSi Mantra device. It retained regulatory and quality compliance firm Elexes for support through the approval process.

The company said in a news release that SSi Mantra is one of the only systems in the world to be distinctly cost-effective with broad-spectrum surgical applications. That includes cardiac surgery. SS Innovations already received regulatory approval from Indian authorities and validated the system in more than 40 different procedures.

Designed to support advanced, affordable and accessible robotic surgery, SSi Mantra provides capabilities for multi-specialty uses. Its uses span cardiothoracic, head and neck, gynecology, urology, general surgery and more. The system features a modular, 3D vision, open-console design with superior ergonomics. It engages machine learning models to improve safety and efficiency during procedures.

“As SS Innovations prepares to pursue regulatory approvals for our SSi Mantra surgical robotic device in Europe and the United States, we are very pleased to have retained Elexes to facilitate the process,” said Dr. Sudhir Srivastava, CEO, chair and founder of SS Innovations. “Elexes has an excellent reputation and track record of success and has previously worked with some of the foundational companies in the medical robotic field, including its key personnel’s experience with Intuitive Surgical and Stryker. We feel confident in the organization’s ability to guide us to achieving FDA and CE approvals in 2024 and 2025.”

Filed Under: Business/Financial News, Food & Drug Administration (FDA), Health Technology, Regulatory/Compliance, Robotics, Surgical Tagged With: SS Innovations