In this article from RGA’s ReFlections newsletter, Dr. Steve Woh highlights Skin Analytics' DERM platform, the first AI system to receive EU regulatory approval for making autonomous clinical decisions on skin cancer detection without human oversight.
In a landmark moment for digital healthcare, UK-based innovator Skin Analytics has secured EU regulatory approval for DERM, its autonomous artificial intelligence (AI) skin cancer detection platform. This makes it the first AI system globally authorized to make clinical decisions on skin cancer without human oversight.
Using a high-resolution image captured with a dermatoscope, DERM electronically analyzes the lesion or mole, delivering a suspected diagnosis along with tailored recommendations for the most appropriate next steps in patient care.
DERM has earned the prestigious Class III CE mark under the EU Medical Device Regulation (MDR), the highest level of regulatory scrutiny for medical devices. This milestone not only validates the system’s clinical robustness but also signals a new era in AI-driven diagnostics.
With a 99.8% accuracy rate in ruling out skin cancer – surpassing the 98.9% benchmark set by dermatologists – DERM is poised to transform dermatological care. Its deployment has already demonstrated the ability to slash waiting times for skin cancer assessments from months to mere days. This is a critical improvement amid a global shortage of dermatologists, with Europe averaging just 30 specialists per one million people.
As an example, the UK has seen a 170% surge in urgent skin cancer referrals within the past decade, with greater than 11% of patients waiting more than a month for evaluation. DERM has already assessed more than 110,000 cases across the UK, showcasing strong real-world performance and scalability.
This regulatory green light paves the way for wider adoption across Europe and other CE-recognizing regions. More important, it sets a powerful precedent for responsible AI integration in clinical workflows, offering a scalable solution to workforce shortages and enabling earlier, more accessible cancer detection.
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