Enspectra’s AI-Powered Imaging Platform for Skin Cancer Gets Breakthrough Status

Enspectra Health has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its next-gen, artificial intelligence (AI)-powered VIO skin platform.
 
VIO evaluates lesions that are suspect of basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) in certain high-risk populations. The platform combines the FDA-cleared VIO technology with VIO.ai NMSC, a CADx/CADt (computer-aided diagnosis and triage) software function that produces lesion classification.
 
Enspectra’s novel technology combines reflectance confocal and multiphoton laser scanning microscopy to create real-time, multispectral images at the cellular level, without needing an incision. The tech allows for an instantaneous evaluation of rich, digital pathology images of various skin tissues, with the goal of minimizing unnecessary biopsies and facilitating earlier disease diagnosis.
 
BCC and SCC are the most common forms of skin cancer and account for nearly all non-melanoma skin cancer (NMSC) diagnoses in the United States. While BCC and SCC generally pose lower mortality risk than melanoma, certain high-risk patients are much more likely to experience NMSC disease progression, increasing morbidity and mortality in these populations.
 
“When identified early, appropriate treatment can be delivered for non-melanoma skin cancer,” said Sarah T. Arron, MD, Ph.D., board-certified dermatologist & Mohs surgeon and clinical advisor to Enspectra Health. “Early intervention aids in the prevention of cancer recurrence and spread.”
 
“Attaining breakthrough designation for our next generation technology underscores the need for a non-invasive assessment option in non-melanoma skin cancer,” added Gabriel Sanchez, Ph.D., CEO and co-founder of Enspectra Health. “We are honored to work closely with the FDA to bring advanced AI/ML tools to dermatology for better patient care.”