FDA Awards Breakthrough Device Designation to Enspectra Health’s AI Platform for Classifying Non-melanoma Skin Cancers
The U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation for Enspectra Health’s next generation artificial intelligence (AI)-powered VIO Skin Platform (VIO) for the evaluation of lesions suspicious for basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) in select high-risk populations. This novel platform integrates the FDA cleared VIO technology with VIO.ai NMSC, […]