{"id":"34aec096-0484-4591-b8c1-f65bd183344f","companyId":"6bbb447e-0278-4ae1-822d-8b546420511e","modelName":"Versius","slug":"cmr-versius","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.","formFactor":"surgical","maturityStage":"commercial","lifecycleState":"active","supersededByModelId":null,"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)"},"manufacturerSerial":null,"reviewStatus":"reviewed","sources":[{"url":"https://www.globenewswire.com/news-release/2024/10/15/cmr-surgical-versius-fda-de-novo","title":"CMR Surgical receives US FDA De Novo for Versius (cholecystectomy; Oct 2024)","sourceName":"CMR Surgical (GlobeNewswire)"},{"url":"https://www.therobotreport.com/cmr-surgical-receives-fda-clearance-for-versius-plus-surgical-robot/","title":"CMR Surgical FDA 510(k) for Versius Plus (Dec 18 2025; US launch 2026)","sourceName":"The Robot Report"},{"url":"https://www.massdevice.com/cmr-surgical-200-million-funding/","title":"CMR Surgical raises $200M+ to fund US/Asia commercialization (Apr 2025)","sourceName":"MassDevice"},{"url":"https://www.globenewswire.com/news-release/2026/03/17/cmr-surgical-nvidia-igx-thor","title":"CMR Surgical + NVIDIA IGX Thor (evaluating AI for next-gen Versius; R&D-stage)","sourceName":"CMR Surgical (GlobeNewswire)"},{"url":"https://www.cambridgeindependent.co.uk/news/cmr-surgical-redundancies","title":"CMR Surgical 2023 redundancies (~350; historical restructuring)","sourceName":"Cambridge Independent"}],"aliases":["Versius","Versius Plus","CMR Versius"],"collisionRisk":"low","reviewNote":null,"manufacturerTermForTeleop":null,"createdAt":"2026-06-03T20:12:29.087Z","updatedAt":"2026-06-03T20:12:29.087Z","jsonLd":{"@context":"https://schema.org","@type":"Product","@id":"https://registry.deploy.report/models/cmr-versius","url":"https://registry.deploy.report/models/cmr-versius","name":"Versius","alternateName":["Versius","Versius Plus","CMR Versius"],"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.","identifier":"34aec096-0484-4591-b8c1-f65bd183344f","category":"surgical","publisher":{"@id":"https://deploy.report/#organization"}}}