Scarlet raises $50M Series B to scale AI and software medical device certification

Scarlet Secures $50M Series B

Scarlet, a London-based certification body for AI and software medical devices, has raised a $50 million Series B round. The funding was led by Headline, with participation from Entrepreneurs First, Atomico, Creandum, Kindred Capital and Notion Capital.

What Scarlet Does

Scarlet positions itself as the only notified body designated under the EU Medical Device Regulation that specialises exclusively in software and AI. The company was founded in 2021 by James Dewar and Jamie Cox, who previously built medical AI at Babylon Health.

Scarlet holds designations from the EU, the UK's MHRA and the US FDA, where it is recognised as a Third Party Review Organisation. Customers upload technical documentation to its AI-enabled platform, where qualified reviewers assess submissions and issue certification decisions.

Customer Base

Scarlet's clients include Flo Health, DeepHealth, NHS England, Skin Analytics, Heidi Health and Tandem Health.

Deal Context

• Round: Series B
• Amount: $50 million
• Lead investor: Headline
• Additional investors: Entrepreneurs First, Atomico, Creandum, Kindred Capital, Notion Capital
• Funding date: October 12, 2026
• Headquarters: London

The round brings together a mix of European venture investors around a company operating at the intersection of medical device regulation and AI-enabled software. Scarlet's regulatory designations across the EU, UK and US give it a position in the certification workflow for software and AI-based medical products.

Why It Matters for Acquirers

Scarlet sits in a specialised regulatory niche: certification of software and AI medical devices. Notified body status is a regulated designation, and the company's stated exclusivity in software and AI under the EU MDR is a differentiating attribute. Its customer roster spans consumer health apps, imaging AI, national health bodies and clinical documentation tools, indicating demand across multiple segments of the digital health market.

The Series B provides capital to expand operations following its 2021 founding. For strategic buyers, Scarlet represents exposure to the compliance layer of the medical AI ecosystem, where regulatory review capacity is a gating factor for product commercialisation.