AI Medical Technology's Dermalyser Gains CE Mark for Melanoma Detection

AI Medical Technology has received CE mark approval for its Dermalyser tool, a smartphone-based diagnostic decision support system for melanoma detection, announced in a press release. This approval enables the company to commence commercial operations throughout Europe in 2025.

Dermalyser, designed for use with a dermatoscope, has demonstrated superior performance compared to experienced dermatologists in clinical trials. The tool achieved an AUROC of 0.960, with 95.2% sensitivity and 84.5% specificity, and reached 100% sensitivity for invasive melanomas. These results were validated through a real-world trial conducted at 36 primary care centers across Sweden.

With the CE certification, AI Medical Technology plans to expand its operations in Europe and aims for a U.S. market entry via FDA 510(k) in 2027. The tool's integration into clinical practice is expected to enhance the precision of melanoma detection, offering faster diagnoses and reducing unnecessary surgeries.