ToplineThe FDA has cleared DermaSensor’s first-of-its-kind handheld device that uses artificial intelligence to non-invasively detect skin cancer, the Miami-based device maker announced Wednesday. Key FactsPhysicians may use the device to take spectral recordings of a suspicious skin lesion, which then goes through an AI-powered algorithm to deliver an immediate result, according to DermaSensor’s website. The FDA authorized marketing for the device last week, noting that the device should be used on lesions already assessed as suspicious for skin cancer and should not be the only diagnostic criterion. The FDA is also requiring that DermaSensor conduct additional post-market clinical validation performance testing of the DermaSensor device across demographic groups. Surprising FactAnother study on DermaSensor found that in a clinical cohort of 108 physicians, the DermaSensor device reduced the number of missed skin cancer diagnoses by half—from 18% to 9%.

Source: Forbes January 17, 2024 17:30 UTC