AI Medical Technology (AIM) has achieved a significant milestone with the CE mark approval of its cutting-edge diagnostic tool, Dermalyser—an AI-powered support system for melanoma detection. Designed for use with smartphones connected to a dermatoscope, Dermalyser leverages artificial intelligence to assist clinicians in identifying skin cancer with unprecedented accuracy. The innovation lies in its portability, real-time decision support, and AI capability, which has demonstrated diagnostic performance that surpasses both expert dermatologists and general practitioners.

The importance of this tool is highlighted by its robust clinical validation through the AI-DSMM trial, which was conducted across 36 primary care centers in Sweden. Dermalyser analyzed 253 suspicious skin lesions, successfully detecting all invasive melanomas with 100% sensitivity and a specificity of 92.6%, clearly outperforming traditional diagnostic methods. This level of accuracy has the potential to revolutionize skin cancer diagnostics in primary care settings, allowing earlier and more reliable detection, reducing unnecessary biopsies, and ultimately improving patient outcomes.

With CE mark approval now secured, AIM is initiating a commercial rollout across Europe in 2025 and has plans to enter the U.S. market by 2027 via the FDA’s 510(k) pathway. Clinicians have already expressed confidence in the tool’s potential to transform melanoma detection. As CEO Christoffer Ekström noted, “This marks the culmination of years of innovation dedicated to improving skin cancer diagnosis.” The introduction of Dermalyser marks a pivotal advancement in precision medicine, offering a faster, smarter, and more accessible solution to one of the most dangerous forms of skin cancer.