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.