Scarlet, a certification body focused on AI and software medical devices, has raised US$50 million in a Series B round led by Headline. The funding includes participation from new investor Notion Capital and existing investors Atomico, Creandum, Kindred Capital, and Entrepreneurs First. Nancy Xiao McLaughlin, Partner at Headline, will join Scarlet's board as part of the investment.
A Faster Path for AI Medical Devices
The development of AI medical devices has outpaced traditional certification processes. Companies can train a diagnostic model in weeks but often wait 12 to 18 months for expert assessment, with an additional 6 to 8 months for minor update approvals. Scarlet was created to remove that friction and accelerate safe access to healthcare innovation.
A Unique Regulatory Position
Scarlet is a government-designated certification body under the EU Medical Device Regulation. Among roughly 52 designated organizations, the company reports that it is the only one specialized in software and AI and built to support iterative AI development. It holds designations from the EU, the UK's MHRA, and the US FDA, where it is recognized as a Third Party Review Organization.
An AI-Native Certification Model
Customers upload technical documentation to Scarlet's AI-enabled platform in any format, and qualified reviewers assess submissions against relevant regulations before issuing certification decisions. The company certifies the way AI products are actually built through subscriptions that cover ongoing surveillance, annual audits, and product changes. Because every assessment is consistent and evidenced, regulators can see the reasoning behind a certification decision at any time.
Rising Demand and Faster Timelines
Demand for AI medical device certification has increased sharply over the past year. Scarlet reports that customers have cut a year or more from certification timelines for new AI-enabled devices and shortened product-update cycles from months to weeks. The company's model is designed to keep pace with the rapid development of large language models and computer vision systems.
Growing Customer Demand
Scarlet's customers include Flo Health, DeepHealth, NHS England, Skin Analytics, Heidi Health, and Tandem. These organizations are building devices that use large language models and computer vision models across consumer health, radiology, cancer detection, and clinical documentation. Finn Stevenson, co-founder and CEO of Flok Health, said that the ability to release more rapid and frequent upgrades helps ensure patients always have access to world-class care.
Investment and Expansion Plans
Nancy Xiao McLaughlin of Headline said the team is fast, consistent, thorough, and rigorous while being devoted to customers and its mission. James Dewar, Scarlet's Co-founder and CEO, added that the company is building AI-native certification to help customers bring cutting-edge innovation to patients worldwide. The new capital will support expansion in the United States and Asia-Pacific, grow the roster of expert AI reviewers and engineers, and expand certification offerings.
Scarlet was founded in London in 2021 by James Dewar and Jamie Cox after they built AI medical devices at Babylon Health. The company spent its first three years working with regulators to obtain designation before issuing any certificates. With this Series B round, Scarlet is positioned to build a truly global AI certification body and pull medical technology from the future into today.