Scarlet is a London-based certification body for AI and software medical devices and, according to the company, the only notified body designated under the EU Medical Device Regulation that specialises exclusively in software and AI. Founded in 2021 by James Dewar and Jamie Cox after they built medical AI at Babylon Health, it 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; clients include Flo Health, DeepHealth, NHS England, Skin Analytics, Heidi Health and Tandem Health.
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Oct 12, 2026
Latest raise
Funding activity · 1 round
Oct 12, 2026
$50M
Series B
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