Scarlet

Healthtech · Regtech · AI

Funding

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

Regulators built for paper trials now review software that updates itself weekly, and the backlog shows it.

• Scarlet, a London-based certification body for AI and software medical devices, raised a $50 million Series B led by Headline, with new investor Notion Capital joining existing backers Atomico, Creandum, Kindred Capital, and Entrepreneurs First.
• Founded in 2021 by James Dewar and Jamie Cox, former Babylon Health AI engineers, Scarlet reviews technical documentation and issues conformity certificates that let AI-powered medical devices reach market.
• Scarlet holds designations from the EU, the UK's MHRA, and the US FDA, where it's recognized as a Third Party Review Organization, and says it's the only one of roughly 52 EU-designated bodies built specifically for AI and software review.
• Scarlet says standard certification reviews take 12 to 18 months, with another 6 to 8 months of delay for even a minor update to an already-approved product.
• The new capital follows a $17.5 million Series A led by Atomico in June 2024 and a £6 million seed led by Creandum in 2022, pushing total funding to roughly $75 million; valuation was not disclosed.
• Scarlet plans to use the funds to expand into the US and Asia-Pacific, hire more AI reviewers and engineers, and broaden its certification offerings beyond initial approval into ongoing surveillance and audits.
• As AI diagnostic models iterate in weeks, traditional notified-body review cycles built for static hardware have become a structural bottleneck between medical AI breakthroughs and patient access.