Swedish start-up AI Medical Technology today announces results from a clinical trial conducted at 37 Swedish primary care facilities with Dermalyser, a diagnostic decision support system empowered with advanced artificial intelligence (AI). A total of 240 patients seeking primary care for melanoma-suspected cutaneous lesions were included in the prospective, pivotal, confirmatory, multi-centre, non-interventional clinical investigation. Dermalyser (a mobile application) showed remarkable diagnostic performance: 95% sensitivity and 86% specificity, outperforming primary care physicians and dermatologists.
“The remarkably high sensitivity and specificity levels demonstrate the clinical performance and benefit of Dermalyser, particularly since the study was conducted in a real world, primary care setting representing different demographics, personnel, and geographical location”, says Christoffer Ekström, CEO of AI Medical Technology. “We now look forward to finalising the CE marking and preparing for market launch in Europe in Q4, 2023. Simultaneously, we plan to engage US-based clinics in upcoming clinical trials as part of our US market entry strategy”.
Olle Larkö, Professor in Dermatology & Venereology and former Dean at Sahlgrenska University, comments: ”Indeed exciting results, these numbers show potential of not only improving future visual diagnostic accuracy, but also decreasing the amount of workload that dermatologist too often are dealing with in their daily practice. Nevertheless, additional studies are necessary to confirm the positive results. Human–computer collaboration is here to stay and I’m looking forward to its implementation in the field of skin cancer and dermatology in general.
Magnus Falk, Associate Professor in General Practice and Principal Investigator, Department of Health, Medicine and Caring Sciences, Linköping University, comments: “In addition to the primary objective, i.e., the diagnostic precision of the device, we also determined the usability and applicability of Dermalyser in clinical practice. Results from the study will be reported in a clinical publication, but already the clear impression is a high acceptance of Dermalyser as a diagnostic support tool among the medical personnel involved”.
