News and analysis on medical technology
FDA clearedFDA cleared. Stage 4 of 4 (Authorized)

CMR Surgical Begins US Launch of Versius Plus Robot Cleared for Gallbladder Removal

The Cambridge, UK, company used the SAGES meeting in Tampa to introduce its modular surgical robot to US surgeons, three months after FDA clearance.

By News DeskMarch 26, 20262 min read
Four white robotic surgical arms with coloured light bands positioned around a domed training model on an operating table
Versius robotic arms arranged around a surgical training model. Photo: CMR Surgical · Company press image published with the release
FDA cleared510(k) · K252111FDA cleared. Stage 4 of 4 (Authorized)

The FDA cleared this device through the 510(k) pathway, which finds it substantially equivalent to a device already on the market. Clearance is not the same as approval.

Key points

  • CMR Surgical said on March 26 that it is launching Versius Plus in the US, starting partnerships with hospitals and ambulatory surgery centers.
  • The FDA cleared Versius Plus under 510(k) K252111 on December 16, 2025, for cholecystectomy in adults 22 and older; the original Versius was granted De Novo authorization in 2024.
  • The company said more than 45,000 patients have been treated with Versius worldwide, in more than 30 countries.

CMR Surgical has begun introducing its Versius Plus surgical robot in the United States, the Cambridge, UK, company announced on March 26 at the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) 2026 annual meeting in Tampa, Florida.

The company said it is starting to build partnerships with hospitals and ambulatory surgery centers ahead of a broader rollout. The launch follows FDA 510(k) clearance of Versius Plus in December 2025 for cholecystectomy, or gallbladder removal.

The clearance behind the launch

The FDA's 510(k) database lists K252111 for the Versius Surgical System (Versius Plus), received July 7, 2025, with a decision date of December 16, 2025. According to the 510(k) summary, the predicate is the original Versius Surgical System, authorized through the De Novo pathway as DEN230078. The summary says human factors validation, design verification and preclinical testing in a porcine model supported the modified system for the same procedure.

CMR's release states that the Versius Plus Surgical System "is indicated for adult patients 22 years of age and older, eligible for soft tissue minimal access surgery, for cholecystectomy." The release also notes that the company's ultrasonic dissector instrument is not approved for sale in the United States.

As reported by Fierce Biotech, via a republication on the website of CMR investor Cambridge Innovation Capital, Versius Plus adds near-infrared fluorescence imaging for highlighting blood flow compared with the earlier system, and the original Versius received its De Novo authorization in 2024 for the same cholecystectomy indication (read via Cambridge Innovation Capital).

Global use and US plans

CMR said more than 45,000 patients worldwide have now been treated with the Versius system, which it said is used in more than 30 countries for general, colorectal, urologic, gynecologic and thoracic surgery. The company described Versius as the second most widely used robotic surgery platform globally; that is its own characterization.

Unlike systems fixed in a single operating room, Versius uses a modular design with independent robotic arms that can be positioned around the patient and moved between rooms, the company said.

"This milestone is twofold and reflects the growing global momentum behind Versius and the confidence surgeons have in the platform," said Chief Executive Massimiliano Colella.

Chris O'Hara, president and general manager for the US, said that "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 company did not name its first US customers or disclose pricing.

CMR obtained more than $200 million in funding in April 2025 to support its US commercial launch, Fierce Biotech reported.

Sources

  1. CMR Surgical Announces 45,000 Patients Treated Globally as Robotic-Assisted Surgery Company Makes Its U.S. Debut (page as updated April 29, 2026; facts cited were in the March 26, 2026 version, as confirmed by the Fierce Biotech report of that day), CMR Surgical, March 26, 2026
  2. CMR Surgical kicks off Versius Plus robot's US commercial launch (Fierce Biotech, republished by Cambridge Innovation Capital), Fierce Biotech via Cambridge Innovation Capital, March 26, 2026
  3. 510(k) K252111: Versius Surgical System (Versius Plus) (database record), US Food and Drug Administration, December 16, 2025
  4. K252111 clearance letter and 510(k) summary, US Food and Drug Administration, December 16, 2025