Ex-Babylon engineers’ Scarlet raises $50M from Headline to certify AI medical devices faster

Scarlet has pulled in $50 million in Series B funding, with Headline leading the round and Notion Capital joining as a new backer. The company is built around a simple but painful bottleneck: AI medical devices can be trained in weeks, but certification can drag on for months.

James Dewar and Jamie Cox, both veterans of Babylon Health’s medical AI work, founded Scarlet in 2021 to sit on the other side of that bottleneck. Instead of building the devices, Scarlet reviews them. It works with regulators to get the right designations in place, then decides whether a product can be sold.

The business already sits inside a messy web of medical regulation. Scarlet is described as an EU notified body, approved by the MHRA as a UK approved body, and listed by the US Food and Drug Administration as a recognised third-party review organisation under Scarlet NB B.V. It says its process is faster than the usual route because customers upload technical documentation, reviewers examine it, and the platform keeps a record of every finding for later inspection.

That pitch is clearly aimed at companies that want to move often. Flok Health wants to ship device upgrades twice a month. Scarlet’s customer list also includes Flo Health, DeepHealth, NHS England, Skin Analytics, Heidi and Tandem Health. The company says it is the only specialist in software and AI among roughly 52 bodies designated under the EU Medical Device Regulation.

The money will go into the US and Asia-Pacific, along with more AI reviewers and engineers. Scarlet has not said what it is worth now, or how many people it employs. But the round pushes its total funding beyond $75 million, after a £6 million seed in 2022 and a $17.5 million Series A in 2024.