SS Innovations provided an update about its progress and timeline in gaining U.S. Food and Drug Administration (FDA) approval for its SSi Mantra surgical robotic system.
 
Earlier this year, the company finished its first interactive pre-submission meeting with the FDA about SSi Mantra. SS Innovations said it got useful feedback from the agency about its planned regulatory strategy, biocompatibility assessment, reprocessing validation, and clinical data requirements.
 
Based on the feedback, the company said it will pursue a de novo pathway for SSi Mantra’s premarket submission for numerous indications in parallel. SS Innovations said it plans to have further pre-sub meetings in the coming months and predicts submitting its Investigational Device Exemption (IDE) application in Q1 2025 to begin clinical trials.
 
The company’s planning to conduct clinical trials for abdominal, pelvis, thoracic, and cardiac indications at the same time.
 
SS Innovations cited SSi Mantra’s safety, efficacy, and performance data from clinical use in India as a reason it will meet trial requirements relatively quickly—the robot has already performed all the types of surgical features that approval is being applied for. Under FDA protocols, procedures performed in India can be included in the clinical trial.
 
The company said it will conduct some of the trials in the U.S. It estimates that, barring any unanticipated developments, it should be able to secure its pre-market approvals by the end of 2025.

More about the SSi Mantra surgical robotic system

The system provides the capabilities for multi-specialty usage including cardiothoracic, head and neck, gynecology, urology, general surgery and more. With modular arm configuration, 3D 4K vision open-console design and ergonomics, the system engages with the surgeon and surgical teams to improve safety and efficiency during procedures.
 
It has received Indian Medical Device regulatory approval (CDSCO) and is clinically validated in India in over 80 different types of surgical procedures.