FDA Approves CMR Surgical’s Versius Robot for Cholecystectomies in Adults

FDA Approval:
The U.S. Food and Drug Administration (FDA) has granted marketing authorization for CMR Surgical's Versius Surgical System, a next-generation surgical robot designed for cholecystectomies in adults aged 22 and older.

De Novo Process:
Versius is the first multi-port, soft tissue general surgical robotic-assisted surgical device to be authorized through the FDA's De Novo application process.

Global Usage:
Versius is the second most utilized surgical robotic system globally, with over 26,000 surgical procedures completed across Europe, Latin America, Asia, the Middle East, and Africa.

Compact Design:
Versius is compact and modular, making it suitable for any care setting. It features 3D HD vision, easy-to-adopt instrument control, and ergonomic working positions to reduce stress and fatigue.

Training Program:
CMR Surgical will roll out a state-of-the-art global metrics-based training program, including the Versius Trainer and Versius eLearning platform, to ensure a smooth transition from training to the operating room.

Market Impact:
The approval paves the way for CMR Surgical to enter the U.S. market, expanding the benefits of robotic-assisted surgery with Versius across various care settings.

Future Plans:
CMR Surgical plans to initially partner with a select number of U.S. hospitals and aims to broaden the applications of the Versius system, including pediatric surgeries.