AI that caught 20,000 cancers is now certified for use on smartphones
The world's first regulated medical device technology approved to autonomously assess skin cancer from a smartphone will be unveiled at HLTH Europe.
DERM Zero is the only smartphone-compatible solution CE marked to Class III, 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 assessment.
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 England, 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 clearance, 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 smartphone 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 group. 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.
How Derm Zero works
Derm Zero is powered by DERM, an AI system trained over more than a decade on a large dataset of skin cancer images, including common cancers, pre-cancerous conditions, and benign lesions. Using pattern recognition, it identifies features that may not be visible to the naked eye. Users take a location photo and a close-up photo of a mole through the app. Within seconds, DERM Zero returns a clinical decision: no further action needed or a referral within the provider's specialist pathway for assessment and treatment.