AI Makes Medical History: First Autonomous Skin Cancer Detection System Approved in Europe

Europe (The Uttam Hindu): In a major medical breakthrough, British technology company Skin Analytics has received regulatory approval for its AI-powered skin cancer detection system, DERM making it the world’s first legally authorized autonomous AI for clinical cancer detection. The European Union has granted DERM a Class III CE mark under the Medical Device Regulation (MDR) 2017/745, allowing it to independently assess and rule out skin cancer without the need for a clinician’s review. This milestone positions DERM as the first AI system legally recognized to match or surpass specialist doctors in making critical clinical decisions.

DERM has demonstrated a 99.8% accuracy rate in ruling out skin cancer, exceeding the 98.9% accuracy of dermatologists. The approval comes amid a severe shortage of dermatologists across Europe, with only 30 specialists per 1 million people, leading to prolonged wait times for critical skin cancer checks. In the UK alone, urgent skin cancer referrals have surged by 170% over the past decade, with 11% of patients waiting more than a month to be seen. With more than 110,000 cases already assessed, DERM has proven its effectiveness in real-world settings by significantly reducing wait times for urgent skin cancer diagnoses from months to just days.

Skin Analytics now plans to expand DERM across European healthcare systems, with potential entry into other markets that recognize CE markings. Medical experts have welcomed this advancement, calling it a crucial step in addressing the rising demand for dermatology services amid workforce shortages. Paulus Lips, Medical Director at Arts en Zorg in The Netherlands, praised the innovation, stating that DERM will provide faster and more efficient early detection, ultimately saving lives. CEO Neil Daly described the approval as a "watershed moment in the history of medicine," emphasizing that AI can be safely and ethically integrated into healthcare to enhance access to life-saving diagnoses and treatments.