London-based Scarlet, a certification body for AI and software medical devices, has raised a $50m Series B led by Headline, with new investor Notion Capital joining Atomico, Creandum, Kindred Capital and Entrepreneur First.
Scarlet was founded in London in 2021 by James Dewar and Jamie Cox, who previously built AI medical devices at Babylon Health. The company is a government-designated certification body, the type of organisation that decides whether a medical device can be sold.
It spent its first three years securing designations before issuing a single certificate. It now holds designations from the EU, the UK's MHRA and the US FDA, where it is recognised as a third-party review organisation.
The round
Headline led the Series B, and partner Nancy Xiao McLaughlin joins Scarlet's board. Notion Capital is the only new name on the cap table. Existing backers Atomico, Creandum, Kindred Capital and Entrepreneur First all followed on.
The valuation was not disclosed. Scarlet has not published its total funding to date.
The money will pay for expansion into the US and Asia-Pacific, more expert AI reviewers and engineers, and a wider range of certification services.
The bottleneck it is selling into
Scarlet's pitch is about speed. A company can train an AI diagnostic model in weeks, but it can wait 12 to 18 months for an expert assessment. A minor update can then add a further six to eight months before it is approved.
Roughly 52 organisations are designated under the EU Medical Device Regulation. Scarlet says it is the only one that specialises in software and AI.
Customers upload technical documentation to Scarlet's platform, and qualified reviewers assess it against the relevant regulations before issuing a decision. Clients pay a subscription that covers ongoing surveillance, annual audits and product changes, which gives Scarlet recurring revenue rather than one-off fees.
Who uses it
The customer list includes Flo Health, US radiology group DeepHealth, NHS England and cancer-detection company Skin Analytics. It also includes AI scribe developers Heidi Health and Tandem, both of which have recently raised nine-figure Series B rounds.
Flok Health, another customer, says Scarlet lets it plan device upgrades twice a month. Under a traditional review cycle, that release schedule would not be possible.
What's next
The raise comes as Scarlet moves beyond Europe into its first large overseas markets. With designations already in hand on both sides of the Atlantic, the US push is about winning customers rather than seeking regulatory approval.
Dewar said the company is building AI-native certification to bring new medical technology to patients faster.
Original source: Tech.eu — https://tech.eu/2026/10/12/scarlet-raises-50m-series-b-to-accelerate-ai-medical-device-certification/
