Dermalyser Secures CE Mark in Europe for AI-Powered Melanoma Detection Tool

Image Credit: © Africa Studio - stock.adobe.com

AI Medical Technology (AIM) announced today that it has received CE mark certification for Dermalyser, its artificial intelligence (AI)-driven diagnostic decision support tool for melanoma.¹ This regulatory milestone enables the tool's immediate commercial use across Europe, with a US launch anticipated in 2027 pending FDA 510(k) clearance.

The CE mark confirms that Dermalyser meets the rigorous safety and performance requirements set by the European Economic Area for medical devices.² With this approval, AIM has officially begun its European commercialization campaign.

Smartphone-Based AI Enhances Human Expertise

Dermalyser is a stand-alone medical device software designed for integration with smartphones fitted to dermatoscopes. By analyzing dermoscopic images of suspicious skin lesions, the AI tool delivers a risk score that assists clinicians, particularly those practicing in primary care settings, in determining the likelihood of melanoma.

The tool’s performance was evaluated in the AI-DSMM study, a real-world clinical trial conducted at 36 primary care centers throughout Sweden. The trial assessed 253 skin lesions in 228 patients. Of these, 21 were confirmed melanomas, including 11 thin invasive and 10 in situ cases.

Dermalyser achieved an area under the receiver operating characteristic curve (AUROC) of 0.960. The tool demonstrated an overall sensitivity of 95.2% and an overall specificity of 84.5%. Notably, for invasive melanomas, Dermalyser reached 100% sensitivity and 92.6% specificity.

Expert dermatologists achieved an AUROC of 0.85, while general practitioners scored an AUROC of 0.70. Dermalyser also outperformed other AI-based diagnostic tools currently in use.

Transforming Melanoma Diagnosis at the Point of Care

Christoffer Ekström, CEO and co-founder of AIM, emphasized the transformative nature of the technology and the dedication behind its development.

"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," said Ekström in a news release.¹ "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, MD, chief medical officer at Sand Clinic in Stockholm, highlighted the tool’s clinical significance.

"Integrating Dermalyser into our practice will assist us in detecting melanoma with exceptional precision, right at the point of care," Sandqvist said.¹ "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."

European Launch Now, US on the Horizon

With CE certification secured, AIM will initiate its rollout across European markets immediately, targeting dermatology clinics, general practitioners, and teledermatology services. The company is also preparing its FDA 510(k) submission, aiming for clearance and market entry in the United States by 2027.

References

1. Dermalyser receives CE mark in Europe, paving the way for life-saving melanoma detection tool. News release. CNW Group. May 27, 2025. Accessed May 27, 2025. https://www.prnewswire.com/news-releases/dermalyser-receives-ce-mark-in-europe-paving-the-way-for-life-saving-melanoma-detection-tool-302465180.html
2. Annex I – General safety and performance requirements. In: Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices. European Union. 2017;L117:100–140. Accessed May 27, 2025. https://www.medical-device-regulation.eu/2019/07/23/annex-i-general-safety-and-performance-requirements/