Scarlet raises $50M to review AI device submissions as a notified body

MedDevice Startups Staff · Oct 12 · 2 min read · Via Tech.eu

Scarlet raised a $50 million Series B led by Headline, announced October 12. Notion Capital joined as a new investor alongside Atomico, Creandum, Kindred Capital and Entrepreneurs First. Headline partner Nancy Xiao Mclaughlin takes a board seat.

Scarlet reviews software and AI devices rather than hardware. It holds designation as an EU MDR notified body, an MHRA approved body, and an FDA-recognized third party review organization. Customers upload technical documentation in any format, and Scarlet's reviewers assess it and issue a decision. Named customers include DeepHealth, Skin Analytics, NHS England and Heidi Health.

Founded in 2021 by two former Babylon Health engineers, James Dewar and Jamie Cox, Scarlet spent three years getting designated before it issued a certificate. It sells a subscription covering surveillance, annual audits and product changes, and will put the new money into the US and Asia Pacific. Scarlet says the industry norm is 12 to 18 months of waiting for expert assessment, and 6 to 8 months to approve a minor update.

A subscription gives the reviewer a reason to keep turnaround short, which inverts the usual incentive in an audit relationship.

Questions & Answers

How much did Scarlet raise in its Series B?

Scarlet raised $50 million in a Series B led by Headline, announced October 12, 2026. Notion Capital joined as a new investor, with existing backers Atomico, Creandum, Kindred Capital and Entrepreneurs First participating.

Is Scarlet an EU MDR notified body?

Yes. Scarlet, based in London, is designated as a notified body under the EU Medical Device Regulation, an approved body for the UK MHRA, and a third party review organization recognized by FDA. It reviews software and AI devices rather than hardware.

Who founded Scarlet?

Scarlet was founded in 2021 by James Dewar and Jamie Cox, who previously built AI medical devices at Babylon Health. Dewar is the company's chief executive.

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