Scarlet, the London-based government-designated certification body for AI and software medical devices founded in 2021 by James Dewar and Jamie Cox, raised a $50M Series B led by Headline — with Nancy Xiao Mclaughlin joining its board — with participation from new investor Notion Capital and existing investors Atomico, Creandum, Kindred Capital and Entrepreneurs First, marking a follow-on round after spending its first three years securing designations before issuing certificates. The company is one of roughly 52 organisations designated under the EU Medical Device Regulation and says it is the only one specializing in software and AI, also holding designations from the UK's MHRA and the US FDA as a Third Party Review Organisation, and serves clients including Flo Health — 500M+ downloads — DeepHealth, NHS England, Skin Analytics, Heidi Health and Tandem via an AI-enabled platform where customers pay a subscription covering ongoing surveillance, annual audits and product changes. The article does not disclose revenue, employee count, pipeline or specific use of proceeds, stating only its mission to build AI-native certification to address 12-18 month assessment waits and an additional 6-8 month delay for minor updates to enable iterative AI development.