FDA Authorizes AI-Powered Device DermaSensor for Skin Cancer Detection

The handheld device, designed to assist doctors in evaluating suspicious skin lesions, can detect all three common types of skin cancer.

The FDA has authorized the use of DermaSensor, an AI-powered handheld device that helps doctors detect skin cancer.
The device uses AI-powered spectroscopy technology to assess cellular and below-the-skin's-surface characteristics of lesions on a patient's skin.
DermaSensor can detect all three common types of skin cancer—basal cell carcinoma, squamous cell carcinoma and melanoma.
The device is intended to be used on lesions already assessed as suspicious for skin cancer and should not be the only diagnostic criterion.
The FDA is requiring that DermaSensor conduct additional post-market clinical validation performance testing of the device across demographic groups.