Scarlet, a company focused on the certification of AI-based medical devices, has secured $50 million in a Series B funding round. The investment was led by Headline, with participation from new investor Notion Capital, alongside existing backers Atomico, Creandum, Kindred Capital, and Entrepreneurs First.
Founded in 2021 by former Babylon Health engineers James Dewar and Jamie Cox, the startup has raised over $75 million in total funding to date. Previous rounds included a seed round of £6 million in 2022 and a Series A round of $17.5 million in June 2024.
The company operates as a notified body in the EU, an approved body in the UK, and a recognized third-party review organization by the US FDA. Scarlet specializes exclusively in software and AI medical devices, distinguishing itself from broader certification bodies like BSI or TÜV SÜD.
Scarlet plans to use the new capital to expand its operations into the United States and the Asia-Pacific region. The funds will also support the hiring of additional AI reviewers and engineers, as well as the development of a broader range of certification services.
The platform allows customers to upload technical documentation for regulatory review. Scarlet provides continuous surveillance, annual audits, and support for product adjustments. Its client list includes organizations such as NHS England, Flo Health, DeepHealth, Skin Analytics, Heidi, and Tandem Health.
