CMR Surgical, a global medical technology business, announced that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration for its Versius Plus Surgical Robotic System. The submission seeks clearance to market the device for benign gynaecology procedures such as total hysterectomy, as well as oophorectomy, salpingectomy, and other gynecologic procedures.

Versius is currently the second most utilised surgical robotic system globally outside of the United States, with growing adoption across multiple specialities, including gynaecology. To date, gynecologic procedures represent a large proportion of all Versius cases recorded globally, reflecting strong clinical uptake and surgeon confidence.

“It is an exciting time for CMR as we seek to expand into gynaecology 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, Chief Executive Officer at CMR Surgical. “We already have extensive global experience across gynaecology and other specialities, and this submission reflects our commitment to bringing a versatile, surgeon-centric solution to more hospitals and healthcare systems in the United States.”

Versius Plus, an adaptable and versatile modular system, 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 visualisation on a digitally integrated robotic platform.

The news follows CMR’s announcement that over 45,000 patients have now been treated globally using the Versius Surgical Robotic System.