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AI-Powered Medical Device to Detect Common Skin Cancers Granted FDA Clearance

By: JNCCN 360 Staff
Posted: Thursday, February 1, 2024

On January 17, the health technology company DermaSensor Inc. announced it has received U.S. Food and Drug Administration (FDA) clearance for its real-time, noninvasive skin cancer evaluation system. Intended to enable primary care physicians to provide quantitative, point-of-care testing for various types of skin cancer (including melanoma, basal cell carcinoma, and squamous cell carcinoma), the wireless, handheld device uses artificial intelligence (AI)-powered spectroscopy to identify cellular and subcellular characteristics of lesions in question for skin cancer.

The device was evaluated in the DERM-SUCCESS study, which included more than 1,000 patients from 22 study centers led by the Mayo Clinic. In this study, the device had a sensitivity of 96% across all 224 skin cancers. In addition, negative results from the study reportedly had a 97% chance of being benign across all skin cancers. In a companion clinical utility study of its use by 108 physicians, the device was found to decrease the number of missed skin cancers by half (from 18% to 9%).

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