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Enspectra receives breakthrough status for AI-powered skin imaging platform


The AI-powered VIO Skin Platform can evaluate lesions indicative of basal cell and squamous cell carcinomas.

Enspectra Health has secured breakthrough device designation (BDD) from the US Food and Drug Administration (FDA) for its AI-powered VIO Skin Platform. The imaging platform is aimed at evaluating lesions indicative of basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) in high-risk populations. This designation could expedite the development and review process for the VIO technology, which integrates with VIO.ai non-melanoma skin cancer (NMSC), a computer-aided diagnosis and triage (CADx/CADt) software to assist clinicians in diagnosis and treatment decisions.

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