CE-Marked Smartphone AI Enables Autonomous Skin Cancer Assessment at Point of Care

Skin cancer is among the most common malignancies in Europe, with more than one million non-melanoma cases and over 100,000 melanoma diagnoses each year. Early detection is critical for improving outcomes, but access to specialist assessment often depends on dedicated equipment and hospital visits that can delay care. A new system enables autonomous, clinical-grade skin cancer assessment on a standard smartphone, bringing screening capabilities to primary care, pharmacies, and other community settings.

Skin Analytics has introduced DERM Zero, described as the first smartphone-compatible solution with a Class III CE mark, the European Union’s highest device classification. The system delivers an autonomous clinical decision on a standard smartphone and is built on the same Class III regulated AI that has been used across National Health Service (NHS) skin cancer pathways for six years. The DERM platform is used across 24 NHS hospitals, has assessed more than 230,000 patients, detected more than 20,000 cancers, and conducts roughly one in nine urgent skin cancer assessments in England.

DERM Zero analyzes two user-captured images, a location photograph and a close-up of a mole, using pattern-recognition models trained over more than a decade on images spanning common cancers, precancerous conditions, and benign lesions. Within seconds, it returns a clinical decision indicating either that no further action is needed or that referral through the provider’s specialist pathway is recommended. Unlike existing skin-check apps, the system delivers dermatologist-level reassurance without a second clinician review by identifying low-concern lesions while flagging suspicious ones for medical assessment.

With Class III CE marking, autonomous clinical decisions previously delivered within NHS pathways are now available on a standard smartphone without a dermoscope or hospital appointment. The system is compatible with 33 smartphones, including recent iPhone and Samsung Galaxy models.

DERM Zero was unveiled at HLTH Europe in Amsterdam on June 16, 2026. Skin Analytics is working with European partners to make the system available from June 2026. By removing the need for specialist equipment or a hospital visit, assessments can be performed in seconds within routine healthcare settings.

“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.”

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