❯ Medical AI certifier Scarlet raises $50 million Series B led by Headline

The roundAccording to Tech.eu, London-based Scarlet raised a $50 million Series B led by Headline, with Notion Capital joining and Atomico, Creandum, Kindred Capital and Entrepreneurs First participating. Headline partner Nancy Xiao Mclaughlin joins the board.

How certification worksScarlet is a designated certification body under the EU Medical Device Regulation that reviews AI and software medical devices: customers upload technical files, reviewers assess them against regulations and issue a decision. Customers pay a subscription covering surveillance, annual audits and product changes. It says it is the only one of about 52 such bodies specializing in software and AI, holds UK MHRA designation and US FDA third-party reviewer recognition, and counts Flo Health and NHS England among customers.

Where the money goesThe co-founders built AI medical devices at Babylon Health, and the company spent three years obtaining designation before issuing a certificate. The funds will support expansion into the US and Asia-Pacific and more AI reviewers and engineers. For medical AI companies, review queues often take longer than development, so a software-focused certifier can shorten time to market.

▮ SIGNALThe faster AI medical products iterate, the more regulatory review looks like the bottleneck, and helping companies through it has become a good business.