AI Medical Technology (AIM) has received CE mark approval for Dermalyser, its diagnostic decision support tool for melanoma detection.
With CE certification granted, AIM is launching commercial operations throughout Europe in 2025, with an eye on a U.S. market entry via FDA 510(k) in 2027.
Designed for use on smartphones attached to a dermatoscope, the AI-powered tool has demonstrated superior performance compared to experienced dermatologists and is now cleared for use across Europe.
Dermalyser is a stand-alone Medical Device Software (MDSW).
Its clinical performance was validated through AI-DSMM, a real-world trial conducted at 36 primary care centres across Sweden. The study analysed 253 suspicious lesions across 228 patients, identifying 21 melanomas—11 of which were classed as thin invasive and 10 which were classified as in situ.
Dermalyser achieved an Area Under the Receiver Operating Characteristic curve (AUROC) of 0.960, with 95.2% sensitivity and 84.5% specificity. For invasive melanomas, it reached 100% sensitivity and 92.6% specificity, outperforming both expert dermatologists (AUROC 0.85) and general practitioners (AUROC 0.70).
The device also surpassed competing melanoma diagnostic support tools.
“Dermalyser is now cleared for the European market, and we already have doctors waiting for using our tool—a clear testament to the trust in our solution,” says Christoffer Ekström, CEO and Co-founder of AIM, in a news release. “For me, this is the culmination of years of dedicated and hard work to improve the way skin cancer is diagnosed. I believe we will rapidly gain traction throughout Europe ahead of a US launch in 2027.”
Jennie Sandqvist, Chief Medical Officer at Sand Clinic in Stockholm, Sweden, adds, “Integrating Dermalyser into our practice will assist us in detecting melanoma with exceptional precision, right at the point of care. This is not just a technological breakthrough, it’s a shift in how we approach skin cancer diagnostics. For our patients, it means faster diagnosis, fewer unnecessary surgeries and potentially life-saving decisions made sooner.”
