DERM Zero is one of the only smartphone-compatible solutions 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.
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 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.
