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Robot model

Versius

surgicalcommercialby CMR Surgical

CMR Surgical (founded 2014, Cambridge, UK; private) makes Versius, the genuine challenger among surgical-robot startups and the one that has clearly crossed…

Track Versius
Manufacturer
CMR Surgical
Form factor
surgical
Maturity
commercial
Lifecycle
active
Deployments
5

The verified answer

As of Sep 2026, DEPLOY verifies Versius, a surgical by CMR Surgical (commercial): 5 verified deployments on record. 5 sources back the record.

Regulatory status2 FDA De Novo authorizations1 FDA 510(k) clearance

Versius holds 2 FDA De Novo authorizations and 1 FDA 510(k) clearance, per the DEPLOY registry.

See all 3 filings

Overview

CMR Surgical (founded 2014, Cambridge, UK; private) makes Versius, the genuine challenger among surgical-robot startups and the one that has clearly crossed the regulatory gating event. Versius is a modular multi-arm teleoperated soft-tissue robot that is heavily software-driven, capturing telematic, video, and outcome data. It received US FDA De Novo marketing authorization in October 2024, the first such authorization for a multi-port soft-tissue general-surgery robot, followed by an FDA 510(k) clearance for the next-generation Versius Plus on December 18, 2025 with US commercialization on track for 2026, and a pending gynecology 510(k) submitted on April 29, 2026; it has long been CE-marked and commercial across Europe, Latin America, the Africa-Middle-East region, and Australia, with more than 40,000 procedures completed outside the US by company reporting.

The registry records it at commercial maturity with an active lifecycle. An important current-state correction: the 2021 roughly $3 billion SoftBank-led valuation story is frozen in time, the company went through real restructuring in 2023 with about 350 redundancies, and it was recapitalized with more than $200 million in April 2025, while reported figures of a roughly $3.1 billion 2025 valuation and a potential $4 billion sale are rumor-tier aggregator claims that are not registered.

On AI substance the shipped reality is a data-capture and analytics ecosystem with the surgeon in full control; the physical-AI framing is forward-looking, anchored in a March 2026 NVIDIA IGX Thor partnership to evaluate AI for a future Versius, with no autonomous or AI-assisted intraoperative feature cleared or shipped.

Verified vs. claimed

Maturity stage
commercial(Commercially deployed with revenue-generating operations.)
Sources on file
View all sources →

Key facts

Form factor

modular multi-arm teleoperated soft-tissue surgical robot

Procedures completed

more than 40,000 outside the US (company-reported)

FDA authorization

De Novo marketing authorization October 2024

Recapitalization

more than $200 million in April 2025

Restructuring

approximately 350 redundancies in 2023

Specs

Arms

multi-arm

Notes

Verified: CMR Surgical (founded 2014, Cambridge UK; private) makes Versius, the genuine challenger that crossed the gating event: FDA De Novo Oct 2024 (first De Novo for a multi-port soft-tissue general-surgery robot), FDA 510(k) for next-gen Versius Plus Dec 18 2025 (US commercialization on track for 2026), plus a pending gynecology 510(k) (Apr 29 2026). >40,000 procedures completed ex-US (company-reported). Recapitalized with $200M+ in Apr 2025., Current-state correction (peak-era framing stale): The 2021 ~$3B SoftBank-led valuation story is frozen. The company went through real 2023 restructuring (~350 redundancies). REJECTED as unverified aggregator/rumor-tier: a ~$3.1B 2025 valuation and a ~$4B sale-exploration; current valuation is unconfirmed (cap-flag)., AI-substance: R&D-stage (honest): Shipped substance = data-capture + analytics ecosystem (teleoperated, surgeon in full control). The 'physical AI' is forward-looking: a Mar 2026 NVIDIA IGX Thor partnership to EVALUATE AI for next-gen Versius (~500 hrs anonymized data contributed). No autonomous/AI-assist intraoperative feature is FDA-cleared or shipped., Claimed but NOT verified: ~$3.1B current valuation; ~$4B sale exploration; exact installed unit count (procedure-count >40k is self-reported); any AI-assist feature being commercially available; gynecology indication (submitted, not cleared).

Products

Versius / Versius Plus: modular multi-arm soft-tissue minimal-access robot; teleoperated, software-driven (captures telematic/video/outcome data). FDA De Novo Oct 2024 (Versius, cholecystectomy); FDA 510(k) Dec 18 2025 (Versius Plus, cholecystectomy); 510(k) gynecology submission Apr 29 2026 (pending). CE-marked + commercial across Europe, Latin America, AMEA, Australia.

Form Factor

surgical (modular multi-port / multi-arm teleoperated soft-tissue surgical robot)

Fda clearance

De Novo marketing authorization in October 2024

Clearance body

US FDA

Procedure types

cholecystectomy

Data & sources

Press releases

2

News coverage

1

Web sources

2

5 sources backing this record.View all →

Availability and pricing

Availability
Not sold (internal use)
Price
$750K to $1M (analyst estimate)as of 2024-01-01
Units in field
Not disclosed
Sales model
Not disclosed
Lead time
Not disclosed

Pricing

One-time purchase

$750,000 - $1,000,000 USDanalyst estimateas of 2024-01-01

Source: How Much is a Surgical Robot? — R2 Surgical industry pricing guide

Price status: actual-sale-price = real published price at time of sale; manufacturer-target = vendor target, not yet realized; analyst-estimate = third-party projection, not a vendor figure; not-announced = no price on record.

Prices verified as of Jan 1, 2024

Deployments (5)

  • Versius at United States (multiple hotel chains)announced

    Versius Plus FDA clearance Dec 2025.

  • Versius at Italyoperational

    Policlinico di Milano became the first public hospital in Italy to use the Versius Surgical Robotic System, performing cholecystectomy, lower anterior resection, and other minimally invasive procedures.

  • Versius at Australiaoperational

    Macquarie University Hospital introduced the Versius robotics arm for keyhole surgery in 2021, following TGA approval.

  • Versius at Indiaoperational

    Versius has been installed across approximately 10 or more hospitals in India, including Apollo and Aster facilities, following CDSCO approval for laparoscopic surgery.

  • Versius at United Kingdomoperational

    Versius surgical robot systems have been deployed at multiple UK NHS hospitals, including Royal Papworth Hospital for thoracic surgery, Addenbrooke's Hospital, and Milton Keynes University Hospital, the latter of which…

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Versius on the deployment map

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Recent activity

Every change to this record is dated, sourced, and independently verified where marked.

Full change history →

Deployment-verified media (3)

PRIMARY SOURCE
Courtesy of CMR Surgical

CMR Surgical's overview of Versius Plus, framed around freedom of access by design. The system is surgeon-teleoperated, never autonomous.

From deployment: India

PRIMARY SOURCE
Courtesy of CMR Surgical

CMR Surgical's footage of a robotic cholecystectomy performed on Versius at Manchester Royal Infirmary. Surgeon-teleoperated, never autonomous.

From deployment: India

PRIMARY SOURCE
Courtesy of CMR Surgical

CMR Surgical's introduction of its Versius surgical robotic system. A surgeon teleoperates Versius from a console; it is never autonomous.

From deployment: India

Supply chain (1)

Compute / semiconductor

  • NVIDIANVIDIA IGX Thor industrial AI compute platform -- adopted as early-adopter evaluation for next-generation Versius surgical robotic system; IGX Thor delivers up to 5,581 FP4 TFLOPS AI compute with 400 GBe connectivity for real-time surgical AI inference and decision support; CMR Surgical also contributed anonymized surgical data to NVIDIA Isaac GRooT-H vision-language-action model for healthcare roboticssuppliesannounced

Suppliers appear here when verified with at least two strong sources (maker-official / IR / regulatory / standards-body / verified tier-2). Sources are append-only; corrections add new sources rather than rewrite history.

Regulatory filings (3)

Safety record

1 recall and 4 incidents on record (1 serious, 1 moderate, 3 minor). Most recent: Jul 2026.

serious
1
moderate
1
minor
3
regulatory action
3
recall
1
malfunction
1

Most recent: Jul 2026

Only active incidents are counted. Retracted incidents are excluded from this summary but remain reachable at their canonical URLs.

Incidents affecting Versius (5)

Includes incidents linked directly to this model or to deployments of it. Retracted incidents are excluded from this view but remain reachable at their canonical URLs.

Sources (5)

  1. https://www.globenewswire.com/news-release/2024/10/15/cmr-surgical-versius-fda-de-novo
  2. https://www.therobotreport.com/cmr-surgical-receives-fda-clearance-for-versius-plus-surgical-robot/
  3. https://www.massdevice.com/cmr-surgical-200-million-funding/
  4. https://www.globenewswire.com/news-release/2026/03/17/cmr-surgical-nvidia-igx-thor
  5. https://www.cambridgeindependent.co.uk/news/cmr-surgical-redundancies

Compare Versius

Common questions

What is Versius?
CMR Surgical (founded 2014, Cambridge, UK; private) makes Versius, the genuine challenger among surgical-robot startups and the one that has clearly crossed the regulatory gating event. Versius is a modular multi-arm teleoperated soft-tissue robot that is heavily software-driven, capturing telematic, video, and outcome data. It received US FDA De Novo marketing authorization in October 2024, the first such authorization for a multi-port soft-tissue general-surgery robot, followed by an FDA 510(k) clearance for the next-generation Versius Plus on December 18, 2025 with US commercialization on track for 2026, and a pending gynecology 510(k) submitted on April 29, 2026; it has long been CE-marked and commercial across Europe, Latin America, the Africa-Middle-East region, and Australia, with more than 40,000 procedures completed outside the US by company reporting. The registry records it at commercial maturity with an active lifecycle. An important current-state correction: the 2021 roughly $3 billion SoftBank-led valuation story is frozen in time, the company went through real restructuring in 2023 with about 350 redundancies, and it was recapitalized with more than $200 million in April 2025, while reported figures of a roughly $3.1 billion 2025 valuation and a potential $4 billion sale are rumor-tier aggregator claims that are not registered. On AI substance the shipped reality is a data-capture and analytics ecosystem with the surgeon in full control; the physical-AI framing is forward-looking, anchored in a March 2026 NVIDIA IGX Thor partnership to evaluate AI for a future Versius, with no autonomous or AI-assisted intraoperative feature cleared or shipped.
How much does Versius cost?
Versius is listed at $750,000 to $1,000,000 on the DEPLOY registry. This is an analyst estimate, not an official price.
How Much is a Surgical Robot? — R2 Surgical industry pricing guide
Is Versius actually deployed in the real world?
Yes. Versius is independently verified in real-world operation on the DEPLOY registry, confirmed at named deployment sites with primary sources: not a concept, render, or demo-only.
Is Versius autonomous or teleoperated?
Not verified as fully autonomous. Versius's capabilities on the DEPLOY registry are recorded as teleoperated-assisted, demonstrated-only, or vendor claims (Assists surgery), not independently confirmed to run without a human in the loop.
Who makes Versius?
Versius is made by CMR Surgical, based in Cambridge, United Kingdom, founded in 2014.
Where is Versius deployed?
5 verified deployments of Versius are on the DEPLOY registry, including at United States (multiple hotel chains), Italy, Australia.
Can you buy Versius?
Versius is in commercial deployment and is sold to operators; contact the manufacturer to buy, and see the pricing section for any recorded price.
Is Versius FDA cleared?
Versius has 3 regulatory records on the DEPLOY registry: FDA 510(k) clearance, cleared; FDA De Novo authorization, cleared; FDA De Novo authorization (DEN230078), granted. See the Regulatory filings section for each agency source.
What are alternatives to Versius?
On the DEPLOY registry, comparable surgical robots to Versius include da Vinci (and Ion), Edge Multi-Port Surgical Robot, Edison Histotripsy System, Stryker Mako SmartRobotics.
How does Versius compare to da Vinci (and Ion)?
Versius and da Vinci (and Ion) (Intuitive Surgical · 15 deployments) are both surgical robots on the DEPLOY registry. Versius has 5 verified deployments on record. Compare both records for specs, safety, deployments, and verified-vs-claimed autonomy.
Is Versius a top surgical?
On DEPLOY's intelligence score, which blends verified deployments, safety, adoption, media, and IP signals, Versius ranks in roughly the top 15% of surgical models tracked by the registry.
What is Versius's maturity stage?
Versius is at the commercial stage on the DEPLOY maturity ladder (research, prototype, pilot, commercial, production). Commercial stage means production-grade deployments are operating at named customer sites.
Is Versius safe?
Versius has 5 active incidents on record in the DEPLOY registry. 1 recall and 4 incidents on record (1 serious, 1 moderate, 3 minor). Most recent: Jul 2026. Retracted incidents are excluded from this count.
How does the CMR Versius compare to da Vinci?
The CMR Versius is a modular and portable surgical robot designed to make minimal access surgery more accessible. A da Vinci system costs $1.5M to $2.5M depending on configuration, plus annual maintenance. Versius is designed to be more portable and affordable than da Vinci, with a modular architecture that fits in smaller operating rooms.
CMR Surgical: Versius SurgicalTeck: Next-gen surgical robots vs da Vinci
Methodology: Verified · 5 sources (2 primary) · last reviewed 2026-07-12

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-07-12

Maturity + lifecycle

Maturity stage: commercial

Lifecycle: active

Architectural position

Cohort: surgical

Sources by quality tier

2
primary-company-ir
Company IR disclosure
2
unclassified
Unclassified source
1
secondary-trade-publication
Trade publication

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for Versius.

Recent coverage

Versius in third-party press

CMR Surgical secures 510k clearance of Versius Plus robotic surgical system

Jun 9, 2026

FDA Clears New Robotic Platform for Gallbladder Surgery

Dec 17, 2025

CMR Raises 00M in Series D Funding for Versius Surgical Robots

Jun 1, 2021