Scarlet Raises $50M to Accelerate AI Medical Device Certification
Scarlet Raises $50M to Expand Medical AI Certification Scarlet has raised $50 million in Series B funding to expand its medical device certification platform. Headline led the round, with Notion The post Scarlet Raises $50M to Accelerate AI Medical Device Certification appeared first on Ventureburn .
Scarlet, a London-based startup founded in 2021, has secured $50 million in Series B funding to enhance its medical device certification platform. Headline led the investment round, with Notion Capital, Atomico, Creandum, Kindred Capital, and Entrepreneurs First also participating. Scarlet's total funding now stands at approximately $75 million. The company specializes in certifying software and artificial intelligence medical devices.
Founded by James Dewar and Jamie Cox, Scarlet's platform combines technology with human reviewers to streamline certification timelines. Training a diagnostic model can take weeks, while certification typically requires 12 to 18 months. Even minor updates to medical software can add another six to eight months, delaying patient access to technology improvements.
Scarlet aims to bridge the gap between medical AI development and regulatory assessment by making certification more responsive to software development cycles. Its platform uses AI-native technology to work with regulators for required designations and operates as an EU notified body and UK approved body. The company is also recognized by the FDA as a Third Party Review Organisation.
Customers upload technical documentation to Scarlet's platform, which qualified reviewers assess against applicable regulations before making certification decisions. The subscription model includes ongoing surveillance, annual audits, and product changes. Scarlet records assessment findings and supporting evidence, allowing regulators to examine the reasoning behind certification decisions when required.
Medical AI companies, such as Flok Health, benefit from Scarlet's certification services by enabling frequent medical device updates while meeting regulatory requirements. Frequent updates allow medical software developers to improve their products, but changes must still comply with relevant regulations before reaching patients. Scarlet's approach centers on aligning certification with software development cycles.
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