CMR Surgical Submits Versius Plus Surgical Robot to FDA for Gynecology

CMR Surgical announced it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its Versius Plus surgical robotic system.

The submission seeks clearance to market the device for benign gynecology procedures like total hysterectomy as well as oophorectomy, salpingectomy, and other gynecologic procedures.

According to the company, Versius is the second most used surgical robotic system globally outside of the U.S., with rising adoption across multiple specialties. To date, gynecologic procedures represent a large proportion of all Versius cases recorded across the world.

Versius plus is an adaptable and versatile modular system. It gives surgeons the flexibility to use familiar laparoscopic port placement with the precision of fully wristed instrumentation compatible with 5 mm ports, and advanced 3D visualization on a digitally integrated platform.

“It is an exciting time for CMR as we seek to expand into gynecology in the U.S. and accelerate access to robotic-assisted surgery with Versius Plus in the largest surgical robotic market in the world,” said Massimiliano Colella, CEO of CMR Surgical. “We already have extensive global experience across gynecology and other specialties, and this submission reflects our commitment to bringing a versatile, surgeon-centric solution to more hospitals and healthcare systems in the United States.”

This announcement follows CMR’s achievement of over 45,000 patients being treated around the world using the company’s Versius system.