Policy & Regulation
Swedish AI Medical Technologies to begin trial for AI melanoma diagnostic tool
22 October 2024 -

Let'em know AB announced on Tuesday that Swedish AI Medical Technologies has received approval to initiate a clinical trial focused on Dermalyser, its AI-driven diagnostic support tool for melanoma assessment.

This investor-led, single-center trial will evaluate Dermalyser's effectiveness in determining melanoma thickness using dermoscopy images. Expected to begin in Q4 2024 and conclude by Q4 2025, the trial aims to enhance the accuracy of melanoma diagnosis.

While melanoma detection can be straightforward, distinguishing between invasive and in situ melanomas based solely on dermatoscopic images remains complex. Preoperative insight into melanoma thickness is crucial for optimal surgical planning and patient management. Dr Sam Polesie, the study's lead investigator, said that the primary goal is to identify practical applications for AI in routine healthcare that can enhance clinical decision-making and patient outcomes.

Previous research, published in the March 2024 edition of the British Journal of Dermatology, showed Dermalyser achieving 95% sensitivity and 85% specificity in primary care settings, with rates of 100% sensitivity and 93% specificity for invasive melanomas.

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