FDA Clears Versius Plus Surgical Robotic System for Specified Benign Gynaecological Procedures

CAMBRIDGE, UK — CMR Surgical has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Versius Plus Surgical Robotic System in specified benign gynaecological procedures, marking another important milestone in the company’s US expansion.

The clearance covers benign total hysterectomy, oophorectomy, salpingectomy, adnexectomy, ovarian cystectomy and lysis of adhesions in eligible adult patients aged 22 and over.

This latest milestone builds on CMR’s extensive international experience in gynaecological surgery, where Versius has been used across a wide range of procedures in markets where such procedures are authorised. With its compact, modular design and flexible approach to robotic-assisted surgery, Versius Plus is designed to support surgeons and hospitals in delivering minimally invasive surgical procedures.

The FDA clearance includes a specific contraindication for the use of Monopolar Curved Scissors (MCS) in gynaecological procedures, and recommends the use of Bipolar Graspers, monopolar hook and non-energised Curved Scissors for these procedures. CMR continues to evaluate and develop data relating to MCS for potential future regulatory submissions.

The clinical study supporting the submission consisted of 45 procedures, all of which were completed without conversion to alternative surgical methods.

CMR will continue to work with hospitals and surgeons to support the introduction of Versius Plus in gynaecological surgery in the US, building on the system’s established clinical experience internationally.

The FDA decision relates specifically to the United States and does not itself change existing regulatory authorisations or permitted uses of Versius Plus in markets outside the US.