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Dermalyser Receives CE Mark In Europe, Paving Way to Market for World’s Best Melanoma Diagnostic Decision Support Tool

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."

For more information, please contact: Christoffer Ekström, CEO AI Medical Technology Email: christoffer@aimedtech.com
Phone: +46 704 027101 Barnaby Pickering, 59 North Communications Email: Barnaby.Pickering@59north.bio -END-

About malignant melanoma According to Cancer Today, the incidence of new cases of malignant melanoma in 2020 was over 320,000 worldwide, https://gco.iarc.fr/today/home and every 4 minutes, a person dies of skin cancer. Patient cases are expected to reach almost 500,000 by 2040. Statistics further show that as many as 99% of the cases are curable if they are diagnosed and treated early enough, thus underscoring the importance of continuous self-examination and visiting your doctor in the case of a suspected skin lesion. Early and accurate diagnosis is vital for saving more lives.

About AI Medical Technology AI Medical Technology is a MedTech company at the intersection of artificial intelligence, clinical research, and digital health. Our mission is to empower frontline healthcare providers with faster, more accurate diagnostic tools that improve outcomes for patients—starting with skin cancer. Our flagship product, Dermalyser, is an AI-driven clinical decision support tool designed to assist general practitioners in identifying all major forms of skin cancer. Backed by a diverse team of clinicians, engineers, and entrepreneurs, and supported by early-stage funding in 2021, we are now launching Dermalyser to market while simultaneously expanding with additional clinical validation through ongoing trials. Our vision is clear: to make world-class diagnostics available at the first point of care—where time, accuracy, and early detection matter most. https://aimedtech.com

About Dermalyser Dermalyser is an easy-to-use smartphone application that supports clinicians in diagnosing skin cancer—quickly and accurately. Using a dermatoscope attached to the smartphone, the app captures high-quality images of suspicious skin lesions. Within seconds, its AI engine analyses the image and provides a diagnostic suggestion focused on detecting melanoma, the most aggressive form of skin cancer. Dermalyser is designed to fit seamlessly into daily clinical routines, helping healthcare professionals improve diagnostic confidence, detect melanoma earlier, and take timely action. By enabling more accurate assessments at the point of care, Dermalyser supports better outcomes for patients and contributes to more efficient, cost-effective skin cancer management.