Scarlet raises $50M for AI medical-device certification

Scarlet has raised a $50 million Series B to expand its certification business for AI and software medical devices, Tech.eu reported. Headline led the round. Medical-device developers use Scarlet to take regulated software from technical submission through an expert decision on whether it can be released.

The workflow starts with customers uploading technical documentation in any format to an AI-enabled platform. Qualified reviewers assess the material against the relevant regulations and issue the certification decision; software organizes the evidence, but it does not replace the reviewer. Scarlet says regulators can inspect the reasoning behind each finding.

The relationship continues after the initial certification. Customers pay a subscription that covers ongoing surveillance, annual audits and product changes, turning a one-time approval into continuing compliance work. Tech.eu identified Flo Health, DeepHealth, NHS England, Skin Analytics, Heidi Health and Tandem among Scarlet’s customers.

The bottleneck is time. Tech.eu reported that a company can train an AI diagnostic model in weeks, then wait 12 to 18 months for expert assessment; even a minor update can add six to eight months. Scarlet’s pitch is that a certification process built around changing software can move more quickly without giving up the expert decision.

Scarlet is a government-designated certification body, not just a compliance-software vendor. According to the company, it is the only one of roughly 52 organizations designated under the EU Medical Device Regulation that specializes in software and AI. It also holds a designation from the UK’s MHRA and is recognized by the FDA as a Third Party Review Organization.

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 secure its designations before issuing certificates. It will use the new capital to expand in the United States and Asia-Pacific, hire more reviewers specializing in AI and engineers, and broaden its certification offerings.