Business · Companies · 8 hrs ago
Scarlet raises $50 million to speed certification of AI medical devices
Scarlet, a London-based company founded in 2021, has raised $50 million in a Series B funding round led by Headline.
It certifies software and AI medical devices, assessing whether they meet regulatory requirements before they can reach the market.
The company says medical device developers can train an AI model in weeks but may wait 12 to 18 months for an expert assessment.
It also says minor updates can face another six to eight months of delay.
Scarlet uses an AI-enabled platform to organise submissions, while qualified reviewers make the certification decisions.
The company is designated in the EU and UK and is recognised by the US FDA as a Third Party Review Organisation.
The funding will support expansion in the United States and Asia-Pacific, more expert reviewers and engineers, and a wider range of certification services.
Scarlet raised $50 million in a Series B round led by Headline to expand its certification work for AI and software medical devices.
The London-based company says its certification process can help medical technology reach patients faster.
The funding will support expansion in the United States and Asia-Pacific, hiring more expert reviewers and engineers, and widening its certification offerings.
Scarlet says it is designated by the EU and UK’s MHRA and recognised by the US FDA as a Third Party Review Organisation.
Its customers include healthcare companies and organisations such as Flo Health, DeepHealth and NHS England.
- Who
- Scarlet, a certification body for AI and software medical devices.
- What
- It raised $50 million in a Series B round led by Headline.
- When
- October 12, 2026. The company announced the funding that day.
- Where
- Scarlet is based in London. The funding will support expansion in the United States and Asia-Pacific.
- Why
- To expand its operations, grow its team of expert reviewers and engineers, and widen its certification offerings.
This story does not have two clearly opposing sides.
James Dewar and Jamie Cox founded Scarlet in London after building AI medical devices at Babylon Health.
Scarlet worked with regulators to obtain designation before issuing any certificates.
Scarlet announced its $50 million Series B led by Headline.
- Funding
- $50 million Series B
- Lead investor
- Headline
- New investor
- Notion Capital
- Founded
- 2021 in London
- Regulatory recognition
- Designations from the EU and UK’s MHRA; recognised by the US FDA as a Third Party Review Organisation
- Expansion plans
- United States and Asia-Pacific
What people are saying
We want to release upgrades to our medical device twice a month. We can with Scarlet.
For every day that safe and effective medical technology is not available, someone’s life takes a different course.
Scarlet helps regulation work with and for, not against, innovation.
Sources
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