Scarlet, the regulator-approved body that certifies AI medical devices, raises $50 million to expand into the US and Asia

Scarlet, a government-designated certification body for AI and software medical devices, announced a $50 million Series B on Monday, Oct. 12, 2026, led by Headline with new investor Notion Capital and existing backers Atomico, Creandum, Kindred Capital and Entrepreneurs First. The company decides whether AI medical devices can go on sale in Europe and the UK, and says the money will fund expansion in the US and Asia-Pacific and more expert reviewers.

Everyone wants AI in the clinic; almost nobody talks about the bottleneck between a working model and a legal one. In Europe that gate is a notified body, and most of them were built to inspect pacemakers and hip implants, not software that gets retrained every few weeks. Scarlet's bet is that the referee can move at software speed too, using AI to do the paperwork while humans still make the call. That's a genuinely useful idea, and a slightly awkward one: the company deciding whether an AI device is safe is now venture-funded and paid by subscription by the companies it certifies. That's how notified bodies have always been paid, to be fair, but faster has to stay rigorous. If it does, the next AI scribe or skin-cancer checker reaches patients a year sooner. If it doesn't, regulators will notice, and so will patients.

Scarlet announced a $50 million Series B on Monday, Oct. 12, 2026, led by Headline, with participation from new investor Notion Capital and existing investors Atomico, Creandum, Kindred Capital and Entrepreneurs First. Headline partner Nancy Xiao McLaughlin joins Scarlet’s board. The company has not disclosed its valuation. Those lines are Scarlet’s and Tech.eu’s same-day account of the announcement.

Scarlet is a government-designated certification body: it reviews AI and software medical devices and issues the certifications they need to be sold. It is an EU notified body under the Medical Device Regulation, a UK approved body under the MHRA, and is recognized by the US FDA as a Third Party Review Organization. A notified body is a private organization a government designates to check whether a device meets the rules before it can be sold. The MHRA is the UK’s medicines and devices regulator. The company says it is the only one of roughly 52 bodies designated under the EU MDR that specializes in software and AI. Notion Capital says it also certifies against MDSAP, ISO 13485, ISO 27001 and ISO 42001. Those designations are Scarlet’s and Notion’s.

James Dewar, the chief executive, and Jamie Cox founded Scarlet in London in 2021 after building AI medical devices at Babylon Health. They spent the first three years working with regulators to win designation before issuing any certificates. Those lines are Tech.eu’s and Notion’s account of the founders.

How it works, as Scarlet and Headline describe it: customers upload technical documentation in any format to Scarlet’s AI-enabled platform; qualified human reviewers assess it against the regulations and make the certification decision. Customers pay a subscription covering ongoing surveillance, annual audits and product changes. Scarlet says every finding is evidenced so regulators can see the reasoning behind any decision. Those lines are Scarlet’s, Headline’s, and Tech.eu’s.

The problem Scarlet describes: a company can train an AI diagnostic model in weeks, then wait 12 to 18 months for an expert assessment and another six to eight months for approval of a minor update. Scarlet says its customers have cut a year or more from certification timelines for new AI devices and shortened update cycles from months to weeks. Those timelines are Scarlet’s.

Customers named in the announcement include Flo Health, US radiology company DeepHealth, NHS England, cancer-detection company Skin Analytics, and AI scribe companies Heidi Health and Tandem. Flok Health co-founder and CEO Finn Stevenson said: “We want to release upgrades to our medical device twice a month. We can with Scarlet.” Those names and that quotation are Tech.eu’s account of the announcement.

Dewar said: “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.” That quotation is his, as Tech.eu prints it.

The money will fund expansion in the United States and Asia-Pacific, more expert AI reviewers and engineers, and broader certification offerings. Those uses are Scarlet’s and Tech.eu’s.

The picture is Scarlet’s Series B photograph of co-founders James Dewar and Jamie Cox, smiling outside a sandstone building. It is the company’s announcement photo, carried by Headline. The frame does not print a calendar date.

In plain terms, a London company that governments have designated to say whether AI medical devices can be sold has raised $50 million. Headline led the round. Scarlet says it is the only one of about 52 EU notified bodies that specializes in software and AI, and that the money will pay for a US and Asia-Pacific expansion and more reviewers. The company has not printed a valuation.