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.
Transforming Vision in the Operating Room
The HYPERSNAP® Surgical System captures real-time hyperspectral data to deliver both conventional colour video and functional tissue biomarkers — most notably, video-rate oxygenation maps. This empowers surgeons with previously inaccessible visual information, enabling more confident assessment of tissue viability during surgery.
Hypervision’s technology simultaneously delivers both conventional colour imagery and real-time quantitative tissue oxygenation maps (StO2), extending the surgeon’s visual capability beyond the limits of human vision. This dual-modality view has the potential to make surgical procedures more informed, precise, and safe. Images were captured in a laparoscopic pre-clinical setting with induced ischemia of the large bowel.
By integrating seamlessly into existing surgical workflows, HYPERSNAP® extends surgical vision beyond the limits of the human eye, without requiring injectable dyes or workflow disruption. The system is non-contact, radiation-free, and operates at over 60 frames per second, providing continuous quantitative feedback at every step of a procedure.
HYPERSNAP® is built on the NVIDIA IGX platform, leveraging its high-performance edge computing capabilities to power real-time AI inference in the operating room. This robust enterprise-ready infrastructure ensures reliable, low-latency analytics for clinical-grade performance. HYPERSNAP®’s hybrid workload achieves real-time performance by leveraging NVIDIA CUDA for compute acceleration and NVIDIA TensorRT for AI inference optimisation.
Clinical Value and Indications
The FDA clearance covers general surgical applications, both open and minimally invasive, using compatible exoscopes and rigid endoscopes.
A key clinical application is the mitigation of anastomotic leakage — one of the most devastating complications in gastrointestinal surgery. Anastomotic leakage occurs in up to 15% of colorectal procedures. It is associated with increased recurrence of cancer, emergency reinterventions, prolonged ICU stays, and costs exceeding $50,000 per case.
By offering objective, real-time assessment of tissue oxygenation, a hallmark of tissue perfusion, without the need for contrast agents or delays, HYPERSNAP® aims to support safer surgical outcomes and reduce the burden of such complications. System highlights include real time video overlay of quantitative tissue oxygenation (StO₂), numerical reporting within user-defined regions of interest, seamless integration with both open and minimally invasive workflows, all without requiring dyes, radiation, or contact.
HYPERSNAP® was previously selected for the FDA’s Safer Technologies Program (STeP), underscoring its potential to significantly improve the safety of existing treatment options. It is now the first FDA-cleared system leveraging HSI and AI for intraoperative guidance — a testament to both its innovation and clinical potential.
— Dr Jaco Jacobs, COO and Regulatory Lead
With clearance secured, we are thrilled to initiate a limited market release with select clinical partners. This marks a defining moment for Hypervision — and for the broader potential of real-time quantitative imaging to transform surgical care.
— Dr Michael Ebner, CEO and Co-Founder