Scarlet raises $50M Series B to accelerate AI medical device certification

Scarlet has closed a $50 million Series B led by Headline, with new money from Notion Capital and continued backing from Atomico, Creandum, Kindred Capital, and Entrepreneurs First. Headline partner Nancy Xiao McLaughlin is joining Scarlet’s board.

The company sits in a strange but important gap. AI medical devices can be trained in weeks, yet the review process can take 12 to 18 months, and even a minor update can add another six to eight months before approval. Scarlet’s pitch is simple: if the software can keep moving, the certification process should stop acting like a traffic jam.

It is not a startup pretending to be a regulator. Scarlet is a government-designated certification body, and the company says it is the only one among roughly 52 such organisations under the EU Medical Device Regulation that focuses on software and AI. It also holds designations from the EU, the UK’s MHRA, and the US FDA, where it is recognised as a Third Party Review Organisation.

Founded in London in 2021 by James Dewar and Jamie Cox after they worked on AI medical devices at Babylon Health, Scarlet spent its first three years getting designation before issuing any certificates. Its customers upload technical documentation to an AI-enabled platform, reviewers check it against the relevant rules, and Scarlet decides whether the product can go into the market.

The client list gives the shape of the market. Scarlet says it works with Flo Health, DeepHealth, NHS England, Skin Analytics, Heidi Health, and Tandem, all building around AI systems such as LLMs and computer-vision models. It also certifies the way products are built, not just the end result, through subscriptions that cover ongoing surveillance, annual audits, and product changes. The company says the new funding will go into US and Asia-Pacific expansion, more reviewers and engineers, and a wider set of certification services.