# Versius

Manufacturer: [CMR Surgical](/companies/cmr-surgical)  
Category: surgical

## Summary

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.

## Top line

> 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.

## Readiness

- **Availability** (internal-only): Internal use only (not for retail).
- **Price honesty** (no-price): No price points on file for Versius.
- **Capability honesty** (no-claims): No reviewed capability claims on file for Versius.
- **Real-world use** (commercial): Maturity: commercial. No verified deployments in the registry.
- **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)](https://www.globenewswire.com/news-release/2024/10/15/cmr-surgical-versius-fda-de-novo)._

### 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)](https://www.globenewswire.com/news-release/2024/10/15/cmr-surgical-versius-fda-de-novo)._

## Manufacturer

- [CMR Surgical (https://www.globenewswire.com/news-release/2024/10/15/cmr-surgical-versius-fda-de-novo)](https://www.globenewswire.com/news-release/2024/10/15/cmr-surgical-versius-fda-de-novo)

## Compared to

- [Hugo RAS](/consumer/models/medtronic-hugo)

## 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)

_Canonical: https://deploy.report/models/cmr-versius_