CMR Surgical Versius / Versius Plus

Commercial Medical · #7
Index score 68.5 (#46 overall) · Commercial internationally with 45,000+ patients treated; in the US, first-gen Versius received De Novo authorization in October 2024 and next-gen Versius Plus was 510(k)-cleared in December 2025, with US commercialization beginning in 2026. · Last verified 2026-09-01

Versius is CMR Surgical's compact, modular soft-tissue surgical robot, with over 45,000 patients treated worldwide, making it by CMR's account the second most-used platform after da Vinci. Independent bedside units with 5 mm wristed instruments wheel between operating rooms rather than occupying a dedicated OR. The upgraded Versius Plus gained FDA 510(k) clearance for cholecystectomy in December 2025, and US commercialization began in 2026.

  • More than 45,000 patients treated worldwide; CMR describes Versius as the second most widely used surgical robotic platform globally [source]
  • Versius Plus, the upgraded second-generation system, secured FDA 510(k) clearance for cholecystectomy in December 2025 [source]
  • CMR has raised major private rounds including $600M (2021), $165M (2023) and a further $200M+ to fund its US launch [source]
  • A 510(k) application to expand Versius Plus into benign gynecology, including hysterectomy, has been submitted [source]

Specifications

SpecificationValueConfidenceSource
Configuration Up to 4 instrument bedside units plus a visualization bedside unit reported pmc.ncbi.nlm.nih.gov (2026-09-01)
Arm articulation 8 articulating joints per arm reported pmc.ncbi.nlm.nih.gov (2026-09-01)
Instrument degrees of freedom 7 DoF reported pmc.ncbi.nlm.nih.gov (2026-09-01)
Instrument diameter 5 mm reported pmc.ncbi.nlm.nih.gov (2026-09-01)
Console Open console with head-up display; surgeon can operate seated or standing reported pmc.ncbi.nlm.nih.gov (2026-09-01)
Portability Compact modular units move between departments and ORs; no dedicated OR required verified us.cmrsurgical.com (2026-09-01)
Patients treated globally 45,000+ patients verified us.cmrsurgical.com (2026-09-01)

Every spec is cited to its source with a retrieval date. verified = manufacturer-published · reported = reputable press/analyst. Verify with the manufacturer before purchase decisions.

Change timeline

  1. launch
    CMR kicks off Versius Plus US commercial launch alongside the SAGES annual meeting [source]
  2. milestone
    Versius Plus secures FDA 510(k) clearance; 2026 US commercialization planned [source]
  3. milestone
    FDA grants De Novo marketing authorization for first-generation Versius (cholecystectomy) [source]

Our take

Versius wins on flexibility and footprint: small hospitals and busy mixed-use ORs can adopt robotics without rebuilding around a large fixed system. Its established international record de-risks the technology, but its narrow initial US indication (gallbladder removal) limits near-term US relevance until the pending gynecology clearance and further expansions land. As a venture-funded private company competing with Intuitive, Medtronic and J&J, CMR's staying power depends on continued capital and US traction.

Best suited for

  • Cholecystectomy (US-cleared indication)
  • Multi-specialty minimal access surgery internationally, including general surgery and gynecology
  • Robotics programs in space-constrained or multi-purpose operating rooms

Versius / Versius Plus: common questions

Is the Versius robot available in the United States?
Yes, in early form. First-generation Versius received FDA De Novo authorization in October 2024 and the next-generation Versius Plus was 510(k)-cleared in December 2025, both for cholecystectomy; US commercialization is ramping through 2026.
How much does Versius cost?
CMR Surgical does not publish pricing. Its modular design is marketed as lowering the barrier to entry compared with large fixed systems.
How is Versius different from da Vinci?
Versius uses small independent bedside units for each arm and an open console, so it can move between ORs and fit existing rooms; da Vinci is a larger integrated system with a much bigger installed base and broader US indications.
How many patients have been treated with Versius?
CMR announced more than 45,000 patients treated globally as it made its US debut.

Sources

  1. CMR Surgical — us.cmrsurgical.com, retrieved 2026-09-01
  2. CMR Surgical — us.cmrsurgical.com, retrieved 2026-09-01
  3. Fierce Biotech — fiercebiotech.com, retrieved 2026-09-01
  4. BJUI Compass (via PubMed Central) — pmc.ncbi.nlm.nih.gov, retrieved 2026-09-01
  5. CMR Surgical — us.cmrsurgical.com, retrieved 2026-09-01
  6. Fierce Biotech — fiercebiotech.com, retrieved 2026-09-01

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