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Hypervision Surgical receives FDA Clearance for HYPERSNAP® Surgical System to improve patient safety

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Hypervision Surgical (“Hypervision”) proudly announces that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the HYPERSNAP® Surgical System — the first intraoperative platform to combine Hyperspectral Imaging (HSI) with AI-powered analytics for real-time surgical decision support.

The HYPERSNAP® Surgical System is also the first device to be regulated under a newly established FDA product code for AI/ML-based real-time video augmentation in imaging systems intended for use in endoscopic or open surgical procedures.

This clearance represents a major milestone in advancing surgical precision and safety by bringing quantitative, injection-free, data-driven imaging into the hands of every surgeon.

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