Scarlet raised $50 million in Series B funding to expand its AI medical device certification platform and build what it describes as a global certification body for advanced healthcare technology companies. The round was led by Headline, with participation from existing investors Kindred Capital, Creandum, Atomico, and Entrepreneurs First, along with new investor Notion Capital.
Scarlet said demand for AI medical device certification has increased significantly over the past year as more healthcare companies develop AI-enabled products that require regulatory approval before reaching patients.
The company focuses on reducing the time required to certify new medical technologies while helping developers stay compliant as their products continue to change and improve.
According to Scarlet, customers using its platform have reduced certification timelines for new AI-enabled medical devices by a year or more in some cases.
The company also said it has shortened product-update cycles from months to weeks, letting medical technology developers introduce improvements faster while navigating certification requirements.
Scarlet’s broader goal is to create certification infrastructure designed for a generation of medical devices increasingly powered by artificial intelligence and software.
The company believes traditional certification processes struggle to keep pace with AI products that evolve faster than conventional medical devices.
The new funding will support expansion of Scarlet’s certification capabilities so the company can address a wider range of AI-enabled medical technologies.
Scarlet also plans to grow its team of experts and expand its geographic footprint across the U.S. and Asia-Pacific.
The company said the international expansion will allow it to support a broader group of medical technology developers seeking to bring AI-enabled products to patients across multiple markets.
Scarlet’s strategy centers on helping healthcare technology companies move faster while maintaining the safety and effectiveness standards clinicians, healthcare organizations, and patients need for adoption.
The company said it sees substantial opportunity as artificial intelligence becomes increasingly integrated into diagnostics, clinical workflows, medical devices, and other areas of healthcare.
With the Series B financing, Scarlet plans to continue developing the infrastructure needed to certify AI medical technology across a broader range of products and markets while supporting companies through both initial approvals and ongoing product updates.
