Stockholm, Sweden. May 27, 2025 – AI Medical Technology has received European CE mark approval for Dermalyser, its smartphone-based diagnosis decision support tool designed for melanoma detection.
The efficacy of Dermalyser, which is classified as a stand-alone Medical Device Software (MDSW), has been confirmed in clinical studies, however for the CE mark process, data from AI-DSMM, a real-life clinical trial conducted in 36 primary care centres across Sweden was used1.
The study included 253 lesions of concern discovered across 228 patients. 21 were found to be melanomas, 11 of which were thin invasive melanoma, with 10 being melanoma in situ.
Dermalyser’s ability to identify melanomas was reflected by an area under the receiver operating characteristic (AUROC) curve of 0.960, corresponding to 95.2% and 84.5% sensitivity and specificity, respectively.
For invasive melanomas alone – the most dangerous type – Dermalyser achieved formidable sensitivity and specificity values of 100% and 92.6%, respectively.
In comparison, expert dermatologists demonstrate an AUROC value of 0.85. For general practitioners, this value is around 0.70. Dermalyser is also significantly more specific and sensitive than competing diagnostic support tools.
Now that Dermalyser has received a CE mark, AI Medical Technology will commence its full commercial operations in Europe. The company already has customers and is looking to expand throughout Europe over the course of 2025.
Speaking on the news, AI Medical Technology co-founder and CEO, Christoffer Ekström said: “Naturally, we are delighted that 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. With Dermalyser, doctors can confidently avoid unnecessary referrals and procedures, which results in significant cost savings for healthcare and reduces patients’ anxiety over uncertain skin assessments. For me, this is the culmination of years of dedicated and hard work to improve the way skin cancer is diagnosed: Dermalyser will save lives. I believe we will rapidly gain traction throughout Europe ahead of a US launch in 2027.”
Jennie Sandqvist, Co-founder and Chief Medical Officer of the Sand Clinic, a Stockholm-based longevity center, and user of Dermalyser, added: “At Sand Clinic, our mission is to stay ahead of disease through prevention, performance, and early intervention. 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.”
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