The FDA has granted breakthrough device designation to VIO Skin Platform, an AI-powered tool that evaluates suspicious lesions for skin cancer, Enspectra Health announced in a press release.
VIO Skin Platform (Enspectra Health) can classify lesions as basal cell carcinoma or squamous cell carcinoma, the most common forms of nonmelanoma skin cancer, in select high-risk populations, thereby aiding physicians in their clinical decision-making.
“Attaining breakthrough designation for our next generation technology underscores the need for a noninvasive assessment option in nonmelanoma skin cancer,”