Learnings from the first AI-enabled skin cancer device for primary care authorized by FDA.

The U.S. Food and Drug Administration’s (FDA) recent authorization of DermaSensor, an AI-enabled device for skin cancer detection in primary care, marks a pivotal moment in digital health innovation. Clinically, the authorization of the first AI-enabled device for use by non-specialists for detecting skin cancer reinforces the feasibility of digital health technologies to bridge gaps in access and expertise in medical practice. The authorization also establishes a new regulatory precedent for FDA authorization of medical devices incorporating AI and machine learning (ML) technologies within dermatology. Together, this article uses the DermaSensor authorization to examine the clinical evidence and regulatory implications of emerging AI-enabled technologies in dermatology.