Enspectra Health Receives FDA Breakthrough Device Designation for AI-powered Imaging Platform Targeting Skin Cancer

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Jun 05, 2024, 10:30 ET

MOUNTAIN VIEW, Calif., June 5, 2024 /PRNewswire/ -- Enspectra Health, a health tech company, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its next generation AI-powered VIO™ Skin Platform (VIO) for the evaluation of lesions suspicious of 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 CADx/CADt (Computer-Aided Diagnosis and Triage) software function that provides lesion classification to aid physicians in their clinical decision-making.

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, M.D., Ph.D., board-certified dermatologist & Mohs surgeon and clinical advisor to Enspectra Health. "Early intervention aids in the prevention of cancer recurrence and spread."

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," said 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."

About Enspectra Health
Enspectra Health is an emerging, privately held health tech company pioneering the virtual biopsy to transform the way physicians evaluate a broad spectrum of skin conditions. The Company's novel technology combines reflectance confocal and multiphoton laser scanning microscopy to generate real-time, multispectral images at the cellular level, without the need for an incision. The technology 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. For more information, please visit www.enspectrahealth.com.

SOURCE Enspectra Health