“World’s first” AI skin cancer detection approved in Europe

DERM from Skin Analytics has been awarded EU’s first and only Class III CE marked medical device, making it the world’s first legally authorised autonomous AI for detecting cancer according to the company.

British technology company, Skin Analytics, has achieved regulatory approval for its autonomous AI skin cancer detection system DERM. According to the company, this milestone makes DERM the world’s first legally authorised AI to independently make clinical decisions on skin cancer without oversight.

DERM achieves a 99.8% accuracy rate in ruling out cancer, which it says surpasses the performance of dermatologists, who typically achieve 98.9%. This unprecedented capability offers patients faster results, reducing months-long waiting times for critical skin cancer checks to just days.

This approval comes as healthcare systems worldwide buckle under unprecedented dermatologist shortages with patients waiting months for potentially life-saving skin cancer checks. With an average of only about 30 dermatologists per 1 million population in Europe the scarcity of practitioners is stark particularly when considering that skin-related issues consistently rank among the top 10 reasons for initial doctor visits. In the UK alone NHS England says urgent skin cancer referrals have skyrocketed 170% in the last decade while 11% of urgent cases wait over a month just to be seen. 

The Class III CE marking under the European Medical Device Regulation (MDR) 2017/745 reflects the highest level of regulatory scrutiny and underlines DERM’s safety, accuracy and effectiveness in detecting cancer in patients without clinician review. It now paves the way for the expansion of DERM across European healthcare systems which face rising demand for dermatology services amid critical workforce shortages.

“This isn’t just an AI approval – it’s the first-time regulators have determined that artificial intelligence can match or exceed specialist doctors in making critical clinical assessments,” said Neil Daly, founder and CEO of Skin Analytics. “DERM can now independently clear patients it determines don’t have cancer, without requiring a doctor to check its work. We have been hearing about AI in healthcare for many years now but this is a real watershed moment in the history of medicine.”

Skin Analytics’ success story exemplifies the strength of British innovation in AI. Having secured its place as a market leader, the company is on a fast trajectory for growth, with plans to deploy DERM widely across European healthcare settings. The regulatory approval also opens doors to other countries that recognise CE markings, significantly broadening DERM’s global impact.

Daly added: “As we expand DERM’s deployment across Europe we are setting new standards for responsible AI adoption in healthcare. This means maintaining rigorous clinical governance, partnering closely with healthcare providers and ensuring our technology enhances rather than disrupts existing care pathways. Our goal is to demonstrate how AI can be safely and ethically deployed to expand access to potentially life-saving early detection.”

Paulus Lips, Medical Director at Arts en Zorg in The Netherlands said: “DERM represents a remarkable leap forward in the fight against skin cancer. This innovation is a vital advancement in addressing the growing demand for dermatology services, particularly in the face of workforce shortages. The Class III CE mark underscores the accuracy, safety and effectiveness of DERM, paving the way for it to make a significant impact on patient outcomes and healthcare systems across Europe.”

The technology shows great promise for the future of dermatology across Europe; DERM has been deployed widely in the UK with more than 110,000 cases assessed and real-word data demonstrating its transformative impact on healthcare delivery. Across UK deployments, the system is delivering  remarkable results in both clinical accuracy and healthcare efficiency. This high accuracy has translated into significant operational benefits including reducing the need for in-person urgent cancer appointments, translating to wait times reduced from months to mere days for many patients and ultimately, speeding up access to potentially life-saving treatment.

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