Versius

CMR Surgical's Versius (and Versius Plus) is a modular, multi-arm, soft-tissue minimal-access surgical robot from UK-based CMR Surgical, and the international-soft-tissue archetype of DEPLOY's surgical cluster. Its modular multi-arm architecture is a deliberate contrast to the monolithic design of Intuitive's da Vinci: it is teleoperated and software-driven, capturing telematic, video, and outcome data. On regulatory status (a correction worth recording): Versius is US-FDA-cleared for cholecystectomy via a De Novo authorization in October 2024, with Versius Plus cleared via 510(k) on December 18, 2025 (also cholecystectomy) and a gynecology 510(k) submitted April 29, 2026 (pending); it is not broadly 'US-pending', only the gynecology indication is. It is CE-marked and commercial across Europe, Latin America, AMEA, and Australia. As enterprise B2B surgical equipment sold to hospitals, there is no consumer price.

Readiness

Versius is internal use only (not for retail), no capability claims are on file, the model has no verified field deployments in the registry, and no incidents are on record.

Availability

internal-only

Internal use only (not for retail).

see evidence →

Price honesty

no-price

No price points on file for Versius.

see evidence →

Capability honesty

no-claims

No reviewed capability claims on file for Versius.

see evidence →

Real-world use

commercial

Maturity: commercial. No verified deployments in the registry.

see evidence →

Safety record

no-incidents

No incidents on record. No verified deployments either.

What it claims to do

No reviewed capability claims on file.

Price

No reviewed price points on file.

Real-world use

No verified deployments on file for Versius.

Safety record

No incidents on record. No verified deployments either, so the absence is uninformative.

Privacy

No privacy practices disclosed or on file for Versius.

Specs

notes

[{"label":"Verified","value":"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."},{"label":"Current-state correction (peak-era framing stale)","value":"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)."},{"label":"AI-substance: R&D-stage (honest)","value":"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."},{"label":"Claimed but NOT verified","value":"~$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.

formFactor

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

What's under the hood

No brain on file for Versius.

Frequently asked questions

Is the Versius actually available for purchase?

Not available to consumers. In internal use by CMR Surgical.Source: CMR Surgical receives US FDA De Novo for Versius (cholecystectomy; Oct 2024)

What does the Versius cost?

Not announced.

Where is the Versius being used?

No verified field deployments on record.

Is the Versius safe?

No incidents on record, but with no verified field deployments either, the absence is uninformative.

How does the Versius handle privacy?

No privacy practices disclosed or on file for Versius.

Who makes the Versius?

Versius is made by CMR Surgical, based in Cambridge, United Kingdom.Source: CMR Surgical receives US FDA De Novo for Versius (cholecystectomy; Oct 2024)

Compared to

• Hugo RASby Medtronic · surgical

Sources

1. CMR Surgical receives US FDA De Novo for Versius (cholecystectomy; Oct 2024) · https://www.globenewswire.com/news-release/2024/10/15/cmr-surgical-versius-fda-de-novo ↗
2. CMR Surgical FDA 510(k) for Versius Plus (Dec 18 2025; US launch 2026) · https://www.therobotreport.com/cmr-surgical-receives-fda-clearance-for-versius-plus-surgical-robot/ ↗
3. CMR Surgical raises $200M+ to fund US/Asia commercialization (Apr 2025) · https://www.massdevice.com/cmr-surgical-200-million-funding/ ↗
4. CMR Surgical + NVIDIA IGX Thor (evaluating AI for next-gen Versius; R&D-stage) · https://www.globenewswire.com/news-release/2026/03/17/cmr-surgical-nvidia-igx-thor ↗
5. CMR Surgical 2023 redundancies (~350; historical restructuring) · https://www.cambridgeindependent.co.uk/news/cmr-surgical-redundancies ↗