# Scarlet Raises $50 Million Series B Led by Headline to Expand AI Medical-Device Certification

Times of AI Desk · 2026-10-13 · Industry

[https://timesof.ai/2026/10/scarlet-50m-series-b-ai-medical-device-certification](https://timesof.ai/2026/10/scarlet-50m-series-b-ai-medical-device-certification)

> London-based Scarlet, a certification body for AI and software medical devices, raised a $50 million Series B led by Headline, with Notion Capital joining and Atomico, Creandum, Kindred and Entrepreneurs First returning, the company said on Oct. 12. It plans US and Asia-Pacific expansion. Scarlet holds EU, UK MHRA and US FDA third-party review designations and says it cuts a year or more from certification timelines.

London-based **Scarlet**, a certification body for AI and software medical devices, has raised a **$50 million Series B** led by **Headline**, the company said on Monday, October 12. **Tech.eu** reports that the money will fund expansion into the US and Asia-Pacific.

## The round

New investor **Notion Capital** joined, alongside existing investors Atomico, Creandum, Kindred Capital and Entrepreneurs First, according to Scarlet and Tech.eu. Headline partner **Nancy Xiao McLaughlin** joins Scarlet's board, Tech.eu says. Scarlet says the round will let it certify AI "in all its forms," grow its team of experts and expand in the US and APAC.

## What Scarlet does

Scarlet is a government-designated certification body. Among roughly 52 organisations designated under the EU Medical Device Regulation, it is the only one that specialises in software and AI, according to the company as reported by Tech.eu. It also holds UK MHRA designation and is recognised by the US FDA as a Third Party Review Organisation.

Tech.eu writes that a company can train an AI diagnostic model in weeks and then wait 12 to 18 months for an expert assessment. Scarlet says its customers have cut a year or more from certification timelines for new AI-enabled devices and shortened update cycles from months to weeks.

**James Dewar** and **Jamie Cox** founded Scarlet in London in 2021 after building AI medical devices at Babylon Health, and spent its first three years working with regulators to obtain designation before issuing certificates, Tech.eu reports.

## Limits

- The timeline savings are the company's claims; no customer data was published.
- The "only specialist" status is Scarlet's own description.

## Sources

- [Scarlet: Scarlet's $50m Series B: Building a global AI certification body (October 12, 2026)](https://www.scarlet.cc/blog/scarlet-s-50m-series-b-building-a-global-ai-certification-body)
- [Tech.eu: Scarlet raises $50M Series B to accelerate AI medical device certification (October 12, 2026)](https://tech.eu/2026/10/12/scarlet-raises-50m-series-b-to-accelerate-ai-medical-device-certification/)