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, a computer-aided diagnosis and triage (CADx/CADt) software function that provides lesion classification to aid physicians in their clinical decision-making.
The Breakthrough Devices Program is reserved for novel medical technologies that potentially provide for more effective diagnosis and/or treatment of life-threatening or irreversibly debilitating diseases. It is intended to provide patients with timely access to medical devices that could provide more effective treatment compared to existing approved treatments by expediting their development, assessment, and review.
“Attaining breakthrough designation for our next generation technology underscores the need for a non-invasive assessment option in non-melanoma skin cancer,” says Gabriel Sanchez, Ph.D., CEO and co-founder of Enspectra Health, in a news release. “We are honored to work closely with the FDA to bring advanced AI/ML tools to dermatology for better patient care.”
