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

What happened

Scarlet , the certification body for AI and software medical devices, today announced a $50 million Series B (an early stage of company funding) led by Headline , with participation from new investor Notion Capital and existing investors Atomico, Creandum, Kindred Capital, and Entrepreneurs First. Nancy Xiao Mclaughlin, Partner at Headline, joins Scarlet’s board.

A company can train an AI diagnostic model in weeks and then wait 12 to 18 months for an assessment by experts, with another six to eight months of unnecessary delay for approval of a minor update, slowing down healthcare innovation. AI medical devices are being developed faster than certification bodies can review them.

Among the roughly 52 such organisations designated under the EU Medical Device Regulation, it is, according to the company, the only one that specialises in software and AI, and was truly built to enable AI’s iterative development. Scarlet holds designations from the EU, the UK’s MHRA, and the US FDA, where it is recognised as a Third Party Review Organisation.

Key facts

• Scarlet , the certification body for AI and software medical devices, today — announced: a $50 million Series B led by Headline , with participation from new investor Notion Capital and existing investors Atomico, Creandum, Kindred Capital, and Entrepreneurs First