SS Innovations Provides U.S. Regulatory Update for the SSi Mantra Surgical Robotic System

Core Insights - SS Innovations International, Inc. has successfully completed a human factors validation study for its SSi Mantra surgical robotic system at Johns Hopkins Hospital, marking a significant milestone in its regulatory process [1][2] - The company plans to submit a 510(k) premarket notification to the FDA in the fourth quarter of 2025, aiming for potential market clearance in the first half of 2026 [1][3] - The SSi Mantra has a cumulative installed base of 125 systems across six countries, with over 6,000 surgical procedures performed to date [4] Company Overview - SS Innovations is focused on developing innovative surgical robotic technologies to make robotic surgery more affordable and accessible globally [5] - The SSi Mantra system features a modular design with advanced technology, including multiple robotic arms and a 3D 4K monitor, supporting various surgical specialties [6] Regulatory Pathway - The company has shifted from a De Novo request to a 510(k) regulatory pathway, which is expected to provide speed and cost advantages in the approval process [4] - RQM+, a MedTech-focused CRO, has been engaged to assist with the 510(k) submission [2]