Versius
[commercial]surgical · food-service · 5 deployments in catalog
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).
Manufacturer
CMR SurgicalForm Factor
surgical
Lifecycle
commercial
Operational Reality
Audited
Deployments
5
Target Price
$750K to $1M (analyst estimate)
- SURGICAL
- COMMERCIAL
Description
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.
Key facts & specs
- website
- https://r2surgical.com/blogs/news/how-much-is-a-new-surgical-robot
- maturity
- commercial
- lifecycle
- active
- manufacturer
- CMR Surgical
- deployments count
- 5
- Maturity stage
- commercial
- Arms
- multi-arm
- 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
- Procedures completed
- more than 40,000 outside the US (company-reported)
- F D A authorization
- De Novo marketing authorization October 2024
- Recapitalization
- more than $200 million in April 2025
- Restructuring
- approximately 350 redundancies in 2023
Availability and pricing
- price
- $750K to $1M (analyst estimate) · as of 2024-01-01
- lead time
- Not disclosed
- sales model
- Not disclosed
- availability
- Not sold (internal use)
- units in field
- Not disclosed
- pricing Model
- Not disclosed
Safety record
1 recall and 4 incidents on record (1 serious, 1 moderate, 3 minor). Most recent: Jul 2026.
Supply chain
- NVIDIACOMPUTE / SEMICONDUCTORNVIDIA NVIDIA 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 robotics
NVIDIA NVIDIA 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 robotics
FAQ
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.
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 14% 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.
Deployments
- Versius at Italy[OPERATIONAL]
Italy · Jan 1, 2022
- Versius at Australia[OPERATIONAL]
Australia · Jan 1, 2021
- Versius at India[OPERATIONAL]
India · Jan 1, 2022
- Versius at United Kingdom[OPERATIONAL]
United Kingdom · Jan 1, 2019
- Versius at United States (multiple hotel chains)[ANNOUNCED]
United States (multiple hotel chains) · Dec 1, 2025
Incidents affecting Versius
- CMR Surgical recalls Versius Surgical System consoles due to Secure Boot cybersecurity vulnerability[RECALL]
Jun 9, 2026
- CMR Surgical Versius: hand-controller arm went still and console became unrecoverable, forcing open conversion (FDA MAUDE)[MALFUNCTION]
Apr 7, 2026
- FDA clears CMR Surgical Versius Plus robotic surgical system for gallbladder removal procedures[REGULATORY ACTION]
Jul 1, 2026
- FDA clears CMR Surgical Versius Plus surgical robotic platform for cholecystectomy (510(k))[REGULATORY ACTION]
Dec 17, 2025
- CMR Surgical Versius Plus receives FDA 510(k) clearance for gallbladder surgery[REGULATORY ACTION]
Mar 15, 2026