Cambridge, UK-based CMR Surgical submitted a 510(k) premarket notification to the U.S. Food and Drug Administration on April 29, 2026, seeking clearance to market its Versius Plus Surgical Robotic System for benign gynecology procedures. The filing is the company’s second U.S. indication push for Versius Plus following its December 2025 cholecystectomy clearance.
Why Gynecology
Benign gynecology — hysterectomy, myomectomy and pelvic floor procedures — is one of the highest-volume robotic-surgery markets in the United States, currently dominated by Intuitive Surgical’s da Vinci. CMR is positioning Versius Plus as a more modular, lower-footprint alternative whose individual arms can be wheeled in and out of standard operating rooms. Gynecology accounts for a meaningful share of the more than 45,000 patients already treated globally with first-generation Versius systems.
Versius Plus’ Differentiators
Versius Plus introduces a redesigned digital ecosystem, open surgeon console and improved force-feedback compared to the original Versius. CMR has been positioning it as the spearhead of its U.S. commercial launch in 2026, with the cholecystectomy indication serving as the first beachhead. A gynecology nod would unlock a substantially larger addressable market in the country.
U.S. Market Backdrop
The American surgical-robotics market is more competitive than at any point in its history. Stryker began first cases with its handheld Mako RPS in May 2026, while Medtronic’s Hugo system continues to expand. Johnson & Johnson is expected to submit Ottava for FDA review later this year, raising the stakes for every new robotic-surgery indication filing.
What Comes Next
CMR has not disclosed a target clearance date but said it remains on track for an expanded U.S. rollout in 2026. The company is also pursuing additional 510(k) submissions for upper-GI and colorectal procedures.
Reporting based on coverage from CMR Surgical press releases, GlobeNewswire, MedTech Dive and MassDevice.