AI Medical Technologies announces the start of a clinical trial at 30 Swedish primary care facilities with Dermalyser, a diagnostic decision support system empowered with advanced artificial intelligence (AI).
The study is a prospective, confirmatory multi-centre, non-interventional clinical investigation with the aim to evaluate the clinical safety, performance and benefit of Dermalyser in patients with cutaneous lesions where malignant melanoma cannot be ruled out, examine the user-friendliness of the device itself, and document health economics data.
The trial is expected to be concluded in Q4, 2022.
“The artificial intelligence behind Dermalyser is based on analysing an unrivalled library of 100,000 skin lesion images with the confirmed diagnosis,” says Christoffer Ekström, CEO of AI Medical Technology. “Our solution shows an outstanding performance of 95% sensitivity and 78% specificity – exceeding that of a trained dermatologist – and we now look forward to validating this with real-world data in our clinical study”.
About the study
The clinical study is a multi-centre, prospective clinical trial to assess the diagnostic performance of Dermalyser when identifying malignant melanomas in patients seeking primary care for melanoma-suspected cutaneous lesions.
“Since this study intends to study clinical applicability and diagnostic reliability, it is important to reflect the reality of primary care. Therefore, we intend to include patients from health centres representing different demographics, size, staffing and geographical location across several Swedish regions,” says Magnus Falk, specialist in general medicine and Principal Investigator.
Photo of Christoffer Ekström and the Dermalyser