THE WORLD’S first autonomous AI system for skin cancer detection, DERM, has received Class III CE marking in Europe, achieving 99.8% accuracy in ruling out cancer—surpassing dermatologists’ 98.9%—and slashing wait times for critical assessments from months to days.
Skin cancer diagnostics face mounting pressure amid global dermatologist shortages, with European healthcare systems averaging just 30 specialists per million people. In the UK alone, urgent referrals for skin cancer have risen by 170% over the past decade, while 11% of urgent cases wait over a month for assessment. British tech firm Skin Analytics has pioneered a solution: DERM, an AI system now authorised to autonomously detect skin cancer without clinician oversight, marking a historic leap in medical technology.
DERM’s approval under the EU’s stringent Medical Device Regulation (MDR) 2017/745 followed rigorous evaluation of its safety and efficacy. The system analyses skin lesions using AI trained on over 110,000 real-world cases from UK deployments. Clinical validation demonstrated a 99.8% accuracy rate in ruling out cancer, outperforming dermatologists (98.9%). Real-world data show the technology reduces urgent appointment wait times from months to days by autonomously clearing low-risk cases. In the UK, DERM has already assessed 110,000 patients, streamlining pathways and freeing specialists to prioritise complex cases.
DERM’s approval signals a paradigm shift in cancer diagnostics, offering healthcare systems a scalable tool to address workforce gaps while improving patient outcomes. For clinical practice, integrating autonomous AI could dramatically reduce delays in diagnosis and treatment, particularly in underserved regions. Skin Analytics plans to expand DERM across Europe, emphasising ethical deployment through partnerships with providers and robust clinical governance. Future priorities include adapting the technology for diverse populations and exploring applications in other dermatological conditions. This milestone underscores AI’s potential to augment—not replace—clinical workflows, setting a precedent for responsible innovation in global healthcare.
Katrina Thornber, EMJ
Reference
Skin Analytics. DERM makes medical history as world’s first autonomous skin cancer detection system is approved for clinical decisions in Europe. Available at: https://skin-analytics.com/news/regulatory-certification/derm-class-iii-ce-mark/. Last accessed: 10 March 2025.
