Scarlet raises $50 million to speed up the certification of AI-based medical devices

The London-based notified body, which specialises in medical software and AI, aims to reduce certification lead times, which currently range from 12 to 18 months. Headline is leading this Series B funding round.

Scarlet, founded in London in 2021 by James Dewar and Jamie Cox, has completed a $50 million B series led by Headline. Notion Capital enters capital alongside the historical investors Atomico, Creandum, Kindred Capital and Entrepreneurs First. Nancy Xiao McLaughlin of Headline joined the board.

The bottleneck of certification

Start-up is a certification body designated by the authorities, a function usually performed by general players. Of the 52 notified bodies in Europe, Scarlet is the only one that actually specializes in software and AI. Its starting point: a medical AI model can be trained in a few weeks, but its regulatory assessment often takes 12 to 18 months. The company has designations in the European Union, with the British MHRA and the American FDA.

Customers include Flo Health, DeepHealth, NHS England, Skin Analytics, Heidi Health and Tandem. The funds will be used to establish itself in the United States and Asia-Pacific, recruit AI specialists and expand the range of certifications proposed.