The AI that caught 20,000 cancers in the UK is now certified for use on a standard smartphone
DERM Zero is a world-first – using Class III regulated medical device1 technology to deliver autonomous clinical grade skin cancer assessments from a standard smartphone2
DERM Zero delivers an autonomous clinical decision directly from a standard smartphone, built on the same Class III regulated AI that has been deployed across NHS skin cancer pathways for six years. DERM, the AI platform that powers DERM Zero, is used across 24 NHS hospitals, has assessed more than 230,000 patients and detected more than 20,000 cancers
HLTH, Amsterdam, 16th June 2026 The world’s first regulated medical device technology approved to autonomously assess skin cancer from a smartphone will be unveiled today at HLTH Europe.
DERM Zero is the only smartphone-compatible solution CE marked to Class III1, the EU’s highest medical device classification – the same classification required for devices such as pacemakers. For patients, that means a clinical-grade skin cancer check can now be delivered through their healthcare provider in seconds, in primary care, in a pharmacy, or in community settings, all without requiring a hospital appointment or specialist equipment.
Developed by Skin Analytics, DERM Zero builds on six years of use in clinical pathways across 24 NHS hospitals, where DERM has assessed more than 230,000 patients, identified over 20,000 cancers and has been independently proven to perform at least as well as a face-to-face dermatologist assessment3.
Unlike existing skin check apps, DERM Zero provides dermatologist-level reassurance without the need for a second review by a clinician. Skin lesions with no concern are definitively marked as such, while suspect lesions are flagged for medical assessment.
Trusted to conduct one in nine urgent skin cancer assessments in England4, Skin Analytics has built a large body of evidence operating inside clinical practice where every cancer detected is validated against histopathology – the diagnostic gold standard for cancer.
With the new Class III regulatory clearance1, DERM Zero brings autonomous clinical decisions to a standard smartphone. In practice that means the same autonomous decisions DERM makes inside the NHS are now available without a dermoscope or hospital appointment.
For patients, that removes the biggest barrier to early detection, and early detection is what most often determines survival from skin cancer. For most people, getting their skin checked has meant time off work, a GP visit, and weeks of waiting for a specialist appointment. DERM Zero is the first Class III technology cleared to deliver clinical-standard assessment from a standard smartphone¹ in the time it takes to take a photograph.
It gives Skin Analytics and its partners the foundation to design new models of care built around the patient, not the equipment, the clinic or the wait.
Skin cancer is one of the most common cancers in Europe and one of the fastest growing. Non-melanoma skin cancer is the most frequently diagnosed cancer, with more than a million new cases recorded across Europe each year. Melanoma, the deadlier form, affects more than 100,000 Europeans annually and is rising in nearly every age group5. It is aggressive but highly survivable when caught early. Until now, getting a clinical assessment has meant waiting for a specialist appointment, often at a hospital, often after weeks or months of delay. DERM Zero removes most of those barriers. A skin cancer assessment that previously required a specialist instrument and a clinic visit can now be done in seconds.
Neil Daly, Founder and CEO of Skin Analytics, said: “Over six years, hundreds of thousands of patients and tens of thousands of cancers, Skin Analytics has supported our partners in delivering better skin cancer care. DERM Zero builds on those achievements and allows us to reimagine how patients access care with our partners. By enabling hundreds of millions of smartphones across the EU to conduct clinical quality skin cancer assessments we can fundamentally change patient access and we believe dramatically improve early detection
“We’re building new models of care with partners across Europe. This is the turning point when a skin cancer assessment will become as everyday as getting an ECG for AFib detection on a smartwatch. We see a world where no one dies of skin cancer, and this is how we get there.”
Dr Alexandra Kemp, Consultant Dermatologist and Trust Cancer Clinical Director at Amersham Hospital, part of Buckinghamshire Hospitals NHS Trust said: “As a consultant dermatologist, I’ve assessed thousands of skin lesions for potential skin cancer. Since we first employed DERM in our skin cancer pathway, there has been a great impact on our clinical capacity, and it has made a real difference to the efficiency of the care we can provide. When it comes to skin cancer, we know early diagnosis means better outcomes. To see this technology available on a smartphone, with no specialist equipment required, creates huge possibilities for expanding patient access and enabling earlier diagnosis.”
Skin Analytics is working with European partners to make DERM Zero available from June 2026.
DERM Zero was unveiled at HLTH Europe in Amsterdam on 16th June 2026.