Scarlet raises $50m in Series B funding led by Headline to accelerate medical device certification.
The round included participation from new backer Notion Capital and existing investors such as Atomico and Creandum.
≈ £37.8M at $1 = £0.7557 on 12 Oct 2026
Scarlet operates as a specialist certification body focusing exclusively on software and artificial intelligence medical devices.
Scarlet has secured $50m in a Series B funding round headed by Headline, with participation from new investor Notion Capital alongside returning backers including Atomico, Creandum, Kindred Capital, and Entrepreneurs First. The capital injection will support the company as it scales its operations into the United States and the Asia-Pacific region, while also growing its team of reviewers and engineers.
Founded in 2004, the London-headquartered firm provides streamlined regulatory compliance checks for artificial intelligence medical devices. The business acts as a notified and approved body across multiple jurisdictions, helping developers navigate certification processes that traditionally span many months.
From the founder
"On each day that safe and effective medical technology is not available, a person’s life takes a different turn. That is why Scarlet was created, said Dewar in the announcement. The company is developing AI-native certification to help its customers bring cutting-edge innovations to patients worldwide."
James Dewar
Co-founder at Scarlet
Investor perspective
"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."
Xiao McLaughlin
Partner, Headline
Use of funds
- 01Grow the team
- 02Expand into international markets
- 03Scale operations

