Scarlet Raises $50M Series B: Can AI Speed Up Medical Device Certification?

Medical AI is moving fast. The rules that govern it are not. A software update that improves a diagnostic tool can sit in regulatory review for months before patients ever see it. Scarlet, a London-based certification body built specifically for software and AI medical devices, just raised $50 million to close that gap.

The company's Series B was led by Headline, with new investor Notion Capital joining existing backers Atomico, Creandum, Kindred Capital and Entrepreneurs First, according to Tech.eu. Headline partner Nancy Xiao Mclaughlin joins Scarlet's board.

A Regulator-Grade Business

Scarlet was founded in 2021 by James Dewar and Jamie Cox, who previously built AI medical devices at Babylon Health. They saw firsthand how slow certification could be and set out to build a better notified body, the independent organizations that assess whether medical devices meet regulatory standards.

That meant spending roughly three years working with regulators to earn designation before issuing a single certificate. Today Scarlet is designated in the EU and by the UK's MHRA, and it is recognized by the U.S. FDA as a Third Party Review Organisation. Among the roughly 52 bodies designated under the EU Medical Device Regulation, the company says it is the only one specializing in software and AI.

How It Works

Customers upload technical documentation in any format to Scarlet's AI-enabled platform. Qualified human reviewers then assess it against the relevant regulations and issue a certification decision.

Instead of one-off fees, customers pay a subscription that covers ongoing surveillance, annual audits and product changes. That model fits software companies that ship updates constantly.

The problem Scarlet targets is significant. An expert certification assessment can take 12 to 18 months, and approval for even a minor update can add six to eight months. For AI products that improve with every release, those timelines are a serious drag.

Customers and Traction

Scarlet's client list includes Flo Health, U.S. radiology company DeepHealth, NHS England, Skin Analytics, and AI scribe companies Heidi Health and Tandem.

"For every day that safe and effective medical technology is not available, someone's life takes a different course," said Dewar, Scarlet's co-founder and CEO.

Mclaughlin framed the investment around the relationship between rules and innovation, saying Scarlet "helps regulation work with and for, not against, innovation."

What Comes Next

Scarlet plans to use the funding to expand in the United States and Asia-Pacific, grow its team of AI reviewers and engineers, and broaden its certification offerings.

The timing is notable. Healthcare AI companies are raising large rounds, and regulators on both sides of the Atlantic are under pressure to keep pace. A certification body that can review faster without lowering standards could become critical infrastructure for the entire sector.

The open question is scale. Certification depends on qualified human reviewers, and growing that bench while maintaining regulator trust will define whether Scarlet can keep up with demand.

Source

Tech.eu — "Scarlet raises $50M Series B to accelerate AI medical device certification"