Scarlet raises $50 million series b to expand AI medical device certification

The funding is earmarked for expansion in the United States and Asia‑Pacific, allowing Scarlet to grow its pool of expert AI reviewers and engineers and broaden its certification services. Scarlet, designated by the EU, the UK’s MHRA and the US FDA as a third‑party review organisation, claims to be the only EU‑designated body that focuses exclusively on software and AI. Its platform lets customers upload technical documentation for assessment, covering ongoing surveillance, annual audits and product changes. Clients include Flo Health, DeepHealth, NHS England, Skin Analytics, Heidi Health and Tandem, all developing AI models such as LLMs and computer‑vision systems.