FDA Approves First AI-Powered Skin Cancer Diagnostic Tool
Source: Targeted Oncology, January 2024
DermaSensor provides quantitative, point-of-testing identification for skin cancer, including melanoma, basal cell carcinoma, and squamous cell carcinoma.
The DermaSensor device uses artificial intelligence (AI)-powered spectroscopy to identify cellular and subcellular characteristics of lesions.
The approval follows an observational study (NCT05126173) that evaluated the device in over 1000 patients and was led by the Mayo Clinic.
The FDA has approved DermaSensor, the first AI-powered tool to diagnose skin cancer, including melanoma, basal cell carcinoma, and squamous cell carcinoma, at the point of testing and noninvasively.
DermaSensor is a wireless, handheld device that uses spectroscopy technology to examine lesions at cellular and subcellular levels, then analyze those characteristics using an FDA-cleared algorithm.1 The device was evaluated in the DERM-SUCCESS study which was led by the Mayo Clinic across 22 study centers and enrolled over 1000 patients. The DermaSensor device demonstrated a 96% sensitivity across all 224 types of skin cancers. Further, negative results from DermaSensor had a 97% chance of being benign across all skin cancers.