AI Medical Technologies Receives Approval for AI Melanoma Thickness Trial

Swedish AI Medical Technologies has announced approval for a clinical trial aimed at further validating the performance of Dermalyser, its advanced AI-driven diagnostic support tool for assessing melanoma. 
 
The primary goal of this investor-led, single-center, non-randomized, parallel, double-blinded, prospective clinical investigation is to evaluate Dermalyser’s ability to accurately determine melanoma thickness using dermoscopy images. The trial is expected to start in Q4 2024 and be concluded in Q4, 2025.
 
“In a previous study, published in March 2024 in the peer-reviewed British Journal of Dermatology, Dermalyser demonstrated a high level of sensitivity and specificity when used by primary care physicians, achieving rates of 95% and 85%, respectively. These figures rose to 100% sensitivity and 93% specificity for detecting invasive melanomas,” said Christoffer Ekström, CEO of AI Medical Technologies. “I am happy to announce the approval to embark on the next study in the clinical validation program for Dermalyser as we strive for making it easier, faster, and more reliable to diagnose for patients with skin lesions suspected to be cancerous.”
 
Dr. Sam Polesie, Consultant Dermatologist and Associate Professor at the Department of Dermatology and Venereology at Sahlgrenska Hospital, Gothenburg, and the lead investigator in the study, commented: “This trial seeks to determine whether AI-powered tools like Dermalyser can enhance our ability to assess melanoma thickness. Such insights can help prioritize patients for surgery, guide surgeons on optimal excision margins during the first operation, and provide patients with more accurate information before surgery.”  
 
While melanomas are often easy to detect, determining whether they are invasive (i.e., malignant cells infiltrating in the dermis and risk for metastasis) or in situ (i.e., cells confined to the upper layer of the skin and no risk for metastasis) can be challenging based on dermatoscopic images alone. Although surgery is required regardless of melanoma depth, having a better understanding of the melanoma’s thickness preoperatively brings benefits for both surgeons and patients.
 
Dr. Polesie added: “The primary goal is to identify practical applications for AI in routine healthcare that can enhance clinical decision-making. One promising use case is the preoperative assessment and profiling of lesions suspected to be melanoma, particularly in estimating their thickness. We believe this represents a strong starting point for integrating AI to support diagnostic accuracy and improve patient outcomes.”