Scarlet Raises $50 Mn Series B to Speed Up Certification of AI Medical Devices

Oct 13, 2026 | By Oliver Bennett

Scarlet, a certification company for AI and software-based medical devices, has raised $50 million in a Series B funding round. The round was led by Headline, with participation from new investor Notion Capital and existing investors Atomico, Creandum, Kindred Capital, and Entrepreneurs First.

SUMMARY

Scarlet raised $50 million in a Series B funding round.
The round was led by Headline, with participation from Notion Capital, Atomico, Creandum, Kindred Capital, and Entrepreneurs First.
Scarlet was founded in London in 2021 by James Dewar and Jamie Cox.

Nancy Xiao McLaughlin, a partner at Headline, will join Scarlet’s board of directors.

AI-powered medical devices are being developed faster than they can be approved. Building an AI diagnostic model can take just a few weeks, but certification by experts can take 12 to 18 months. Even minor updates can face another six to eight months of delays, slowing the development and use of new healthcare technologies.

“For every day that safe and effective medical technology is not available, someone’s life takes a different course. Scarlet exists to solve this problem,” said James Dewar, Scarlet’s Co-founder & CEO.

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“Scarlet helps regulation work with and for, not against, innovation. James and Jamie experienced the legacy certification process firsthand and decided to become the AI-native market enabler, starting with certifying AI and software as medical devices,” said Nancy Xiao McLaughlin, Partner at Headline.

Certify your AI medical device without unnecessary delays.

James Dewar and Jamie Cox founded Scarlet in London in 2021 after working on AI-powered medical devices at Babylon Health. During its first three years, the company worked with regulators to get the necessary approvals before it began issuing certificates.