DermaSensor Obtains FDA Clearance Extension for its AI Skin Cancer Detector

The wearable device, combining optical spectroscopy and AI, improves the ability of general practitioners to detect skin cancer by 12.5%.

Already approved by the FDA in 2024 as the first AI device dedicated to skin cancer screening in general practice, DermaSensor obtained a new authorization in June 2026 expanding its use. The device combines elastic scattering spectroscopy (ESS) with an AI algorithm that interprets the signal collected in a few seconds by simply placing an optical probe on a suspicious lesion, without any invasive procedure.

Advanced clinical data show a sensitivity of 95.5% for all skin cancer categories — melanoma, basal cell carcinoma and squamous cell carcinoma. The tool is said to improve the detection rate of primary care physicians by 12.5%, and reduce the proportion of missed cancers from 18% to 9% when used in addition to the traditional clinical examination.