The archive · Health & Care · Product decision · 2014–2026
CMR Surgical bets a portable robot can dent da Vinci; FDA clearance opens the US in 2026
Modular Versius robot wins FDA clearance and $200M+, challenging Intuitive's US monopoly
CMR Surgical
What the business is
Medical-device company making Versius, a compact modular surgical robot for soft-tissue minimally invasive surgery, sold and serviced globally plus a digital surgery ecosystem.
Starting capital：$600M Series D (2021) at ~$3B valuation; $165M (Sep 2023); $200M+ equity and debt (Apr 2025)
How it started
Founded in 2014 in Cambridge, England by five founders including surgeon Mark Slack and engineer Luke Hares, after asking why so many patients still don't get minimal access surgery. Versius won CE marking in 2019 and began rolling out across Europe, Asia and Latin America.
What happened
Raised $600M in a June 2021 Series D at a reported ~$3B valuation, then $165M in September 2023 as Versius passed 15,000 cases. In October 2024 the FDA granted the original Versius marketing authorization via the De Novo process for cholecystectomy; in April 2025 CMR closed a $200M+ round with Trinity Capital as a new debt investor to fund the US launch; in December 2025 the upgraded Versius Plus received 510(k) clearance, also for cholecystectomy.
How it ended up
Still scaling: Versius Plus commercialization in the US is underway in 2026, with a 510(k) submission pending to expand into gynecology and pediatric and transoral trials running.
Background
CMR Surgical's bet is that robotic surgery is under-adopted not because surgeons don't want it but because the dominant platform is a huge, expensive, dedicated-room machine. Founded in Cambridge in 2014 by five founders including surgeon Mark Slack and engineer Luke Hares, the company built Versius as a modular, portable system with small individually positioned arms and an open console, designed to work in a standard operating room with no dedicated infrastructure.
The strategy was validated outside the US first: Versius won CE marking in 2019, spread to more than 30 countries, and passed 30,000 surgical cases, making it the second most-adopted soft tissue surgical robot worldwide. CMR raised $600M in a 2021 Series D at a reported ~$3B valuation, another $165M in September 2023, and more than $200M in April 2025 with new debt investor Trinity Capital, explicitly to fund the United States launch.
The US market opened in steps: the FDA granted the original Versius De Novo marketing authorization in October 2024 for cholecystectomy, and in December 2025 cleared the upgraded Versius Plus via 510(k) for the same indication, with CMR on track to commercialize in 2026. As of mid-2026 the company is expanding the platform into gynecology through a pending 510(k) and running pediatric and transoral robotic surgery trials.
What has to be true
- The founders started from a clinical observation — most patients still get open surgery — rather than from a technology looking for a use.
- Designing for existing ORs and budgets attacks the real adoption barrier: da Vinci's $2M+ price tag and dedicated-room footprint.
- International traction (30,000+ cases, 30+ countries) gave the US entry credibility and data before FDA clearance.
- The December 2025 Versius Plus 510(k) gives CMR a second-generation platform rather than a first-generation product in its most important market.
What can be applied
Challengers beat an incumbent not by out-featuring it but by changing the constraint: make the product fit the customer's existing room and budget, and the market definition itself shifts.
Aftermath
As of September 2026, CMR Surgical is executing the US launch of Versius Plus following its December 2025 FDA clearance, with commercial rollout targeted for 2026 and a 510(k) submission to expand into gynecology already filed. Globally the system had completed more than 30,000 surgical cases in 30+ countries, with pediatric and transoral trials ongoing.
Sources
- CMR Surgical secures more than $200M to accelerate growth
- FDA Clears New Robotic Platform for Gallbladder Surgery
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