SS Innovations to Submit De Novo Application to the FDA for the SSi Mantra 3 Surgical Robotic System for Multiple Indications

Core Insights - SS Innovations International, Inc. plans to submit a De Novo Classification Request to the FDA for the SSi Mantra 3 surgical robotic system in July 2025, aiming to enhance market access in the U.S. [1][2] Company Overview - SS Innovations is focused on developing innovative surgical robotic technologies to make robotic surgery affordable and accessible globally [6]. - The company has already marketed its SSi Mantra surgical robotic system in six countries and is pursuing further global expansion [5]. Product Performance - Since the launch of the SSi Mantra system in August 2022, 80 systems have been installed in 75 hospitals, with over 3,800 surgeries performed, including more than 200 robotic cardiac surgeries [3]. - The SSi Mantra 3 version, launched in June 2024, has seen 37 installations and over 750 multispecialty robotic surgical procedures, including 70 cardiac cases, with no device-related mortality or complications reported [3][4]. Clinical Validation - Real-world clinical data, validated by a leading contract research organization, supports the safety and efficacy of the SSi Mantra 3 for a variety of surgical procedures [4]. - The planned FDA submission will include applications for multispecialty indications such as urology, gynecology, general surgery, and thoracic and cardiac surgery [4]. Technological Features - The SSi Mantra Surgical Robotic System features a modular design with 3 to 5 robotic arms, an ergonomic surgeon command center, and advanced imaging capabilities, including a large 3D 4K monitor [7]. - It utilizes over 40 different types of robotic endo-surgical instruments to support various specialties, including cardiac surgery [7].