❯ Medical AI certifier Scarlet raises $50 million to expand into the US and Asia-Pacific

Headline leadsScarlet announced on October 12 a $50 million Series B led by Headline, with Notion Capital joining and Atomico, Creandum, Kindred Capital and Entrepreneurs First returning; no valuation was disclosed. Headline partner Nancy Xiao Mclaughlin joins the board.

Medical software must pass it to launchIn Europe, AI medical software needs certification from a designated body before launch. Scarlet is one, saying it is the only one of about 52 that specializes in software and AI; it is also designated by the UK’s MHRA and recognized by the US FDA as a third-party reviewer. Certified reviewers decide; software only speeds the process.

Three years to qualifyFounders James Dewar and Jamie Cox built medical AI at Babylon Health and started Scarlet in 2021, spending three years obtaining designation before issuing a certificate. It charges a subscription covering surveillance, annual audits and reassessment of updates; customers include Flo Health, NHS England, Skin Analytics and AI scribes Heidi and Tandem.

A year savedScarlet says customers have cut a year or more from certification of new AI devices, and update reviews from months to weeks. The money goes to entering the US and Asia-Pacific, adding experts and certifying more forms of medical AI.

Every update means another waitAI medical software updates often and each change may need reassessment. A diagnostic model can be trained in weeks yet wait over a year for review. If Scarlet gets updates through faster, medical AI companies can iterate much faster.

▮ SIGNALThe faster medical AI iterates, the more review becomes the bottleneck, and helping companies through it has become a good business.