The USFDA has approved DermaSensor, a revolutionary AI-driven tool for on-the-spot and noninvasive skin cancer diagnosis for physicians. It covers screening for various cancers like melanoma, basal cell carcinoma, and squamous cell carcinoma. The wireless, handheld device utilizes spectroscopy technology to scrutinize lesions at cellular and subcellular levels, employing an FDA-approved algorithm for comprehensive analysis. The DERM-SUCCESS study, conducted at 22 centers with over 1000 patients, revealed a remarkable 96% sensitivity for DermaSensor across 224 skin cancer types. In a parallel clinical utility study involving 108 physicians, DermaSensor was found to reduce missed skin cancer diagnosis by half (18% vs. 9%). DermaSensor’s breakthrough device designation in 2021 paved the way for its recent FDA clearance, marking a significant medical achievement after 12 years and millions of dollars in research and development. Cody Simmons, DermaSensor’s CEO, emphasized the device’s role in empowering primary care physicians with an automated tool for assessing suspicious skin lesions, addressing a longstanding unmet need in medicine.
