Scarlet, a certification body for AI and software medical devices, has raised £40 million in a Series B round 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 funding will support Scarlet’s expansion in the United States and Asia-Pacific, growing its roster of expert AI reviewers and engineers, and expanding its certification offerings.
AI medical devices are being developed faster than certification bodies can review them. A company can train an AI diagnostic model in weeks but then wait 12 to 18 months for an assessment by experts, with another six to eight months of delay for approval of a minor update. These timelines slow down healthcare innovation and limit how quickly safe and effective medical technology reaches patients. Scarlet is a government-designated certification body that specialises in software and AI and is built to enable AI’s iterative development.
Scarlet holds designations from the European Union, the United Kingdom’s MHRA, and the United States FDA, where Scarlet is recognised as a Third Party Review Organization. Among roughly 52 organisations designated under the EU Medical Device Regulation, Scarlet is the only one that specialises in software and AI. Customers upload technical documentation to Scarlet’s AI-enabled platform in any format, after which qualified reviewers assess submissions against relevant regulations and issue certification decisions on whether products can be released into the market.
Customers are typically building devices that use cutting-edge AI such as large language models and computer-vision models. Named customers include Flo Health, which reports over 500 million downloads, US radiology company DeepHealth, NHS England, cancer-detection AI company Skin Analytics, and AI scribe providers Heidi Health and Tandem, both of which recently announced nine-figure Series B fundraises. Scarlet also certifies how AI products are built, with customers paying a subscription that covers ongoing surveillance, annual audits, and product changes.
Because every assessment is consistent and every finding is evidenced, regulators can see the reasoning behind any certification decision at any time. Scarlet spent its first three years working with regulators to obtain designation before issuing any certificates. Scarlet was founded in London in 2021 by James Dewar and Jamie Cox after they built AI medical devices at Babylon Health.
Scarlet has built a Notified Body for the AI world. The ability to release more rapid and frequent upgrades to our medical device ensures that our patients always have access to world-class care. We want to release upgrades to our medical device twice a month. We can with Scarlet.
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. We’re building AI-native certification to help our customers bring cutting-edge innovation to patients around the world.
Scarlet helps regulation work with and for, not against, innovation. James and Jamie experienced the legacy certification process firsthand and decided to become the AI-native market enabler, starting with certifying AI and software as medical devices. Scarlet has superpowers that seem at odds: they are fast, consistent, thorough, and rigorous. The team is devoted to its customers and takes seriously its mission to get life-saving technology to people faster. We’re excited to lead the Series B and for everything ahead.
