Scarlet, the certification body for AI and software medical devices, today announced a $50 million Series B led by Headline, with participation from new investor Notion Capital and existing investors Atomico, Creandum, Kindred Capital, and Entrepreneurs First. Nancy Xiao Mclaughlin, Partner at Headline, joins Scarlet’s board.
AI medical devices are being developed faster than certification bodies can review them. A company can train an AI diagnostic model in weeks and then wait 12 to 18 months for an assessment by experts, with another six to eight months of unnecessary delay for approval of a minor update, slowing down healthcare innovation.
Scarlet is a government-designated certification body. Among the roughly 52 such organisations designated under the EU Medical Device Regulation, it is, according to the company, the only one that specialises in software and AI, and was truly built to enable AI’s iterative development. Scarlet holds designations from the EU, the UK’s MHRA, and the US FDA, where it is recognised as a Third Party Review Organisation.
James Dewar and Jamie Cox founded Scarlet in London in 2021 after building AI medical devices at Babylon Health. The company spent its first three years working with regulators to obtain designation before issuing any certificates.
Customers upload technical documentation to Scarlet’s AI-enabled platform in any format. Qualified reviewers then assess the submission against relevant regulations and ultimately issue a certification decision, deciding whether the product can be released into the market or not.
Customers are typically building devices that use cutting-edge AI such as LLMs and computer-vision models, and include consumer giants like Flo Health, who boast over 500 million downloads, US radiology behemoth DeepHealth, the UK’s NHS England, cancer-detection AI company Skin Analytics, and AI Scribes such as Heidi Health and Tandem, who both recently announced nine-figure Series B fundraises.
Scarlet also certifies the way AI products are actually built. Customers pay 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 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,” said Finn Stevenson, co-founder and CEO of Flok Health.
“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,” said James Dewar, Scarlet’s Co-founder & CEO.
“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,” said Nancy Xiao McLaughlin, Partner at Headline.
“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.”
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.