CMR Surgical Submits 510(k) Application to U.S. FDA to Expand Versius Plus into Gynecology

PRESS RELEASE

Following Recent FDA Clearance for Cholecystectomy, the Company is now 510(k) pending for Gynecology. This Submission Builds On Extensive Global Clinical Experience in Gynecology and Continues CMR's U.S. Market Expansion

CAMBRIDGE, UK, April 29, 2026 - CMR Surgical, a global medical technology business, today 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 gynecology procedures such as total hysterectomy as well as oophorectomy, salpingectomy, and other gynecologic procedures.

Versius is currently the second most utilized surgical robotic system globally outside of the United States, with growing adoption across multiple specialties, including gynecology. 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 gynecology 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 gynecology and other specialties, 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 5mm-ports, and advanced 3D visualization 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.

Notes to editors

Robotic-assisted surgery continues to play an expanding role in gynecology, helping surgeons deliver minimally invasive care with potential benefits including reduced hospital stays, faster recovery, and improved patient outcomes.

The company's approach reflects a responsible, evidence-based regulatory progression, building on its initial U.S. authorization and global clinical experience.

CMR Surgical will participate in the upcoming American College of Obstetricians and Gynecologists Annual Meeting, where it will engage with the gynecologic community and share insights from its global experience in robotic-assisted surgery.

About CMR Surgical Limited

CMR Surgical (CMR) is a global medical devices company dedicated to transforming surgery with Versius Plus, a next-generation surgical robot. Headquartered in Cambridge, United Kingdom, CMR is committed to working with surgeons, surgical teams and hospital partners, to provide an optimal tool to make robotic minimal access surgery universally accessible and affordable. With Versius Plus, CMR Surgical is on a mission to redefine the surgical robotics market with practical, innovative technology and data that can improve surgical care. Founded in 2014, CMR Surgical is a private limited company backed by an international shareholder base.

Media Contacts:
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References:

1. Gaia G, Sighinolfi MC, Afonina M, Terzoni S, Iannuzzi V, Felline M, Morandi A, Alboni C, Marca A, Ceretti AP, Bianchi PP, Rocco B, Marconi AM. Versius surgical system: tips and tricks for OR setting and port placement for pelvic surgery, our experience in a multi-robotic referral centre. Langenbecks Arch Surg. 2025 Aug 28;410(1):252. doi: 10.1007/s00423-025-03812-7. PMID: 40874956; PMCID: PMC12394370.
2. Sadlecki P, Walentowicz-Sadlecka M. Feasibility evaluation of the Versius surgical system: robot-assisted hysterectomy for benign and malignant gynaecological lesions. Arch Gynecol Obstet. 2025 Feb;311(2):355-365. doi: 10.1007/s00404-024-07655-3. Epub 2024 Jul 24. PMID: 39046468; PMCID: PMC11890229.
3. Sighinolfi MC, De Maria M, Meneghetti I, Felline M, Ceretti AP, Mosillo L, Catalano C, Morandi A, Calcagnile T, Panio E, Sangalli M, Turri F, Terzoni S, Assumma S, Sarchi L, Afonina M, Marconi A, Bianchi PP, Micali S, Rocco B, Gaia G. The use of Versius CMR for pelvic surgery: a multicentric analysis of surgical setup and early outcomes. World J Urol. 2024 Jan 13;42(1):31. doi: 10.1007/s00345-023-04730-3. Erratum in: World J Urol. 2024 Feb 19;42(1):86. doi: 10.1007/s00345-024-04850-4. PMID: 38217724; PMCID: PMC10787883.
4. Sadlecki P, Walentowicz-Sadlecka M. Hysterectomy for oncological and non-oncological reasons in patients over 70 years of age - comparison of robot-assisted, laparoscopic, and open approaches. J Robot Surg. 2025 Aug 19;19(1):497. doi: 10.1007/s11701-025-02676-9. PMID: 40830484; PMCID: PMC12364973.

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Disclaimer:

Versius Plus Surgical System is 510k cleared by FDA for cholecystectomy in adult patients 22 years of age and older that are eligible for soft tissue minimal access surgery and is 510k pending for gynecology with benign total hysterectomy as well as oophorectomy, salpingectomy, and other gynecologic procedures. This document may contain forward looking statements. Versius Plus is part of a Versius ecosystem comprised of the Versius Surgical System, the EIZO CuratOR product, the vLimeLite visualisation system, and a suite of electrosurgical and nonelectrosurgical instruments in the United States. CMR Surgical, the CMR Surgical logo, vLimeLite and Versius are trademarks or registered trademarks of CMR Surgical in the UK and other jurisdictions. EIZO, the EIZO logo, and CuratOR are trademarks or registered trademarks of EIZO Corporation in Japan and other countries Indocyanine green (ICG) is a drug and is not provided by CMR Surgical and must be independently sourced by the customer. The approval status of the drug may vary by country. The Versius System vLimeLite Instructions for Use, including the approved indications, contraindications and warnings can be found in the product labelling supplied with each Versius Plus System. The Ultrasonic Dissector is not approved for sale in the United States. Versius and its associated products are commercially available in certain geographies. Regulatory requirements of individual countries and regions will determine approval, clearance, or market availability. Please contact your local CMR Surgical representative for product availability in your region. Refer to the product-specific user manual for indications, contraindications, warnings, and other product information. The information is correct at the time of publication of this press release.

Safety Information

The Versius Plus Surgical System is a robotically assisted surgical device that is intended to assist in the precise and accurate control of Versius Plus Surgical endoscopic instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, forceps/pick-ups, needle holders, electrosurgery, and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrosurgery and suturing.

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.