Scarlet raises $50M to speed up AI medical device certification
What's the deal? Scarlet, a certifier of AI medical devices founded by former Babylon HealthDealroom has a profile for this one. Try Dealroom → engineers, has raised $50 million in a Series B round led by Headline. Notion Capital joined as a new investor, alongside existing backers Atomico, Creandum, Kindred CapitalDealroom has a profile for this one. Try Dealroom →, and Entrepreneurs First.
What's the endgame? Founded in 2021, Scarlet decides whether other companies' AI medical devices can be sold. It is an EU notified body, a UK approved body under the Medicines and Healthcare products Regulatory Agency, and a recognised third-party review organisation on the US Food and Drug Administration's list.
Why now? Scarlet's pitch is speed. It says training an AI diagnostic model takes weeks, but assessment runs 12 to 18 months, with minor updates adding six to eight months.
Customers upload technical documentation in any format, and qualified reviewers check it against regulations to decide if a product can ship. The subscription includes continuous surveillance, annual audits, and product adjustments.
By the numbers: The round sits in the 90th percentile for all-time Series B deals in enterprise software, based on a sample of 5,042 rounds. Scarlet raised £6 million in a 2022 seed round and $17.5 million in a Series A led by Atomico in June 2024, bringing total funding past $75 million. It did not disclose its valuation.
Where the money goes: The funds will expand operations in the US and Asia-Pacific, add AI reviewers and engineers, and broaden certification services. Scarlet did not say how many people it employs.
Its customers include Flo Health, with more than 500 million downloads; US radiology provider DeepHealth; NHS England; cancer-detection firm Skin Analytics; and AI scribe companies Heidi and Tandem Health.
"On each day that safe and effective medical technology is not available, a person's life takes a different turn," said co-founder James Dewar.
The signal: Scarlet says it is the only software and AI specialist among the roughly 52 bodies designated under the EU Medical Device Regulation, while incumbents such as BSIDealroom has a profile for this one. Try Dealroom →, TÜV SÜD, and DEKRA certify across many categories. As AI diagnostics multiply faster than regulators can review them, a certification bottleneck is becoming its own market.
Read more: Tech Funding News
Image credit: Scarlet
