London-based Scarlet, which certifies AI and software for medical devices, raised a $50M Series B led by Headline to support its US and Asia-Pacific expansion

You can get your AI medical device certified 12 months faster, reducing time to market.

Scarlet, a London-based company that certifies artificial intelligence and software used in medical devices, has secured $50 million in Series B funding. The round was led by Headline, with participation from Notion Capital and existing investors such as Atomico and Creandum. Nancy Xiao Mclaughlin, a Partner at Headline, will join Scarlet's board of directors. The company's expansion plans include a focus on the US and Asia-Pacific markets. Scarlet addresses the bottleneck in AI medical device development, where the creation of AI diagnostic models can take weeks, but the subsequent certification process can stretch to 12 to 18 months.

The substantial funding indicates a growing market need for specialized AI and software certification bodies in the medtech sector, driven by the rapid pace of AI development outpacing regulatory review capabilities. Scarlet's expansion into the US and Asia-Pacific markets suggests a strategic move to capture a larger share of this expanding global demand.

This investment signals a potential acceleration in bringing innovative AI-powered medical solutions to market, as companies like Scarlet streamline the often lengthy and complex certification processes. Increased competition and efficiency in this niche could lead to broader adoption of AI in healthcare and impact patient care timelines.