AI Enters the Skin Cancer Screening Revolution # Skin cancer is the most common cancer in the United States, yet approximately 25% of cases are misdiagnosed. In January 2024, the FDA authorized DermaSensor, the first AI-enabled dermatologic device cleared for use by non-specialists, opening a new frontier for skin cancer detection in primary care settings.
The High Stakes of Diagnostic AI # When artificial intelligence gets a diagnosis wrong, the consequences can be catastrophic. Missed cancers, delayed stroke treatment, sepsis alerts that fail to fire, diagnostic AI failures are increasingly documented, yet lawsuits directly challenging these systems remain rare. This tracker compiles the evidence: validated failures, performance gaps, bias documentation, FDA recalls, and the emerging litigation that will shape AI medical liability for decades.
Executive Summary # AI medical devices are proliferating faster than regulatory infrastructure can track their failures. With over 1,200 FDA-authorized AI devices and a 14% increase in AI-related malpractice claims since 2022, understanding the liability landscape has never been more critical.