Scarlet Raises $50M to Speed Up Certification of AI Medical Devices
London-based Scarlet, a certification body that specializes in software and AI medical devices, raised a $50 million Series B led by Headline.
KIING DIGITAL LABS · · 3 min read
On Monday, Oct. 12, 2026, London-based Scarlet announced a $50 million Series B to speed up the approval of AI and software medical devices. The round was led by Headline, with Notion Capital joining as a new investor. Existing backers Atomico, Creandum, Kindred Capital and Entrepreneurs First also took part.
What happened
Scarlet is not a typical health tech startup. It is a certification body, the kind of organization that reviews a medical device and decides whether it meets the rules required to be sold. According to Tech.eu, Scarlet is a government-designated body under the European Union's Medical Device Regulation, one of roughly 52 such bodies, and the company says it is the only one that specializes in software and AI.
Tech.eu reports that Scarlet also holds designations from the UK's medicines regulator, the MHRA, and is recognized by the U.S. Food and Drug Administration as a third-party review organization.
The company was founded in London in 2021 by James Dewar and Jamie Cox, who previously built AI medical devices at Babylon Health. According to Tech.eu, Scarlet spent its first three years earning regulatory designation before it issued a single certificate.
Here is how its service works. Customers upload their technical documentation in any format to Scarlet's AI-enabled platform. Human reviewers then assess it against the rules that apply and issue a certification decision. Customers pay a subscription that covers ongoing monitoring, annual audits and product changes.
Named customers include DeepHealth, NHS England, Skin Analytics, Heidi Health and Tandem Health. Scarlet plans to use the new money to expand in the United States and Asia-Pacific, grow its team of AI reviewers and engineers, and add more certification services.
Scarlet has now raised about $75 million in total, according to Tech Funding News and Ventureburn estimates, including a $17.5 million Series A led by Atomico in 2024.
Why it matters
AI products can improve quickly, but medical rules move slowly. Tech.eu reports that an expert assessment can take 12 to 18 months, and that even a minor update can be held up for another six to eight months. For a company that wants to improve its AI every few weeks, that gap is a serious problem.
Scarlet's pitch is that certification can be fast and still be rigorous. Dewar put the stakes plainly: "For every day that safe and effective medical technology is not available, someone's life takes a different course." Headline partner Nancy Xiao McLaughlin, who joins Scarlet's board, said the company "helps regulation work with and for, not against, innovation."
If faster review spreads, patients could get access to safer tools sooner, and medical AI companies could ship improvements on a regular schedule instead of waiting more than a year.
What this means for founders and builders
Even if you never build a medical device, there is a useful lesson here. In many industries, the hardest part of launching software is not writing the code. It is meeting the rules, earning trust and getting approved by the people who control access to customers.
Scarlet built a business around that bottleneck. The same pattern shows up in finance, education, insurance and many other fields: wherever compliance slows things down, there is room for software that makes the process faster and clearer.
When you plan a product, list the approvals, audits or checks your customers must pass and ask whether your software can make those steps easier. That can be a strong selling point on its own.
If you have an idea for a product in a regulated space, a custom build lets you start with a plan that accounts for those requirements from day one. If you would rather start with a finished platform, our acquisitions page lists complete software products ready to take to market.
The bottom line
Scarlet's $50 million round is a bet that the slow approval process for medical AI can be fixed with better software and specialist reviewers. For builders everywhere, it is a reminder that solving a painful compliance problem can be a business in its own right.
Free tool: Have an idea sparked by this news? Turn it into a product plan in minutes with Concept Studio — free. Skip the build: Explore fully built products ready to acquire or start a custom build.
- FUNDING
- HEALTH TECH
- REGULATION
- AI
