Following FDA approval last December for its upgraded robot, CMR Surgical has begun rolling out its Versius Plus platform in the U.S.
The commercial kickoff comes as the Cambridge, U.K.-based company marks 45,000 patients treated by its Versius systems across more than 30 countries, with procedures spanning colorectal, urologic, gynecologic, thoracic and general surgeries.
“This milestone is twofold and reflects the growing global momentum behind Versius and the confidence surgeons have in the platform,” CEO Massimiliano Colella said in a statement. “But equally important, it comes at a watershed moment for CMR as we introduce Versius Plus to the U.S. surgical community and begin expanding access to our technology in the world’s largest robotic surgery market.”
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The former Fierce Medtech Fierce 15 honoree described itself as the second most widely used robotic surgery platform globally, after industry giant Intuitive.
In the U.S., with Versius Plus’ initial clearance for minimally invasive gallbladder removals, CMR said it is starting to build partnerships to place its cart-based laparoscopic robot in both hospitals and ambulatory surgical centers.
“Versius Plus was designed to meet the practical realities of today’s healthcare environment; adaptable across operating rooms, efficient to integrate into existing surgical programs, and scalable for long-term growth,” said Chris O’Hara, CMR’s president and U.S. general manager. “With FDA clearance now in place and additional indications planned, we are focused on partnering with forward-thinking health systems to expand the role of robotic-assisted surgery across specialties and care settings.”
The launch also coincides with presentations at the Society of American Gastrointestinal and Endoscopic Surgeons’, annual meeting, which is being held this week in Tampa, Florida.
Compared to its predecessor, Versius Plus includes near-infrared fluorescence imaging for highlighting blood flow, as well as an ultrasonic dissector instrument. The original Versius claimed a de novo clearance from the FDA in 2024 for the same cholecystectomy indication.
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CMR obtained more than $200 million in April of last year to support its U.S. commercial launch. That followed up on large funding rounds totaling $165 million in late 2023 and $600 million in mid-2021.
