Scarlet Series B lands $50m to certify AI medical devices

Scarlet, a London company that certifies AI and software medical devices, announced a $50 million Series B round on 12 October 2026, according to Tech.eu. Headline led the Scarlet Series B, with Notion Capital as a new investor. Existing investors include Atomico, Creandum, Kindred Capital and Entrepreneurs First.

A phone in a hospital corridor, with torn paper and orange cut-out shapes.

What Scarlet does for AI medical device founders

Scarlet is a government designated certification body, an independent organisation that reviews a medical device before it can be sold. The company says it is the only one of about 52 bodies designated under the EU Medical Device Regulation that specialises in software and AI.

Its designations cover the EU and the UK's Medicines and Healthcare products Regulatory Agency (MHRA), and the US Food and Drug Administration recognises it as a Third Party Review Organisation. Customers upload technical documentation in any format and pay a subscription that covers ongoing surveillance, annual audits and product changes.

Named customers include Flo Health, DeepHealth, NHS England, Skin Analytics, Heidi Health and Tandem.

Medical device certification time limits how fast founders ship

Scarlet says certification can take 12 to 18 months, and that approving a minor update can add six to eight months. Those are company figures, not independent measures.

Take a founder who ships often. Finn Stevenson, chief executive of Flok Health, says his team wants to release upgrades twice a month, which is 24 releases a year, and that it can do so with Scarlet. If reviews ran one after another at six to eight months each, a company could clear only about one and a half to two updates a year.

Reviews can overlap, so the real gap is smaller. Even so, every month spent waiting for a decision is a month of runway, which makes review time a financing issue as well as a regulatory one.

Where the Scarlet Series B money goes

Scarlet plans to expand in the US and Asia Pacific, grow its team of AI reviewers and engineers, and broaden its certification offerings. Nancy Xiao Mclaughlin, a partner at Headline, joins the board and says Scarlet helps regulation work with innovation.

James Dewar, the chief executive, and Jamie Cox founded Scarlet in London in 2021 after building AI medical devices at Babylon Health. The company spent its first three years obtaining designation before issuing any certificates.

Headline and the other investors are paying for a designation that took Scarlet three years to earn and that a competitor cannot replicate quickly. Scarlet joins a run of large UK rounds for companies built on hard science or regulation, including Basecamp Research's $140 million Series C and the British Business Bank's backing for Oxford spinout Living Optics. Founders weighing where to raise can also compare Beauhurst's finding that first time equity deals moved outside London for the first time since 2022.

Key takeaways

• Scarlet announced a $50 million Series B on 12 October 2026, led by Headline with Notion Capital as a new investor.

• Scarlet says it is the only one of about 52 EU designated bodies to specialise in software and AI medical devices.

• The company says certification can take 12 to 18 months and that a minor update can add six to eight months.

• The funds will go to expansion in the US and Asia Pacific, more reviewers and engineers, and broader certification services.

• Sequential reviews at that pace allow about one and a half to two updates a year, against the 24 releases a founder may want.