HyperSnap Surgical System (HSS)
Hypervision SurgicalThe HyperSnap Surgical System (HSS) is an advanced imaging system used during surgery that combines real-time RGB video with hyperspectral imaging to show tissue oxygen saturation. It uses AI and deep learning to reconstruct images and provide instant feedback to surgeons about tissue health, potentially helping identify tissue ischaemia during open or minimally invasive procedures.
Intended Use
The HyperSnap Surgical System is a real-time video camera system utilizing computational hyperspectral imaging in the visible spectrum to relay RGB video feed alongside corresponding tissue oxygenation (StO2) information as a two-dimensional real-time video feed, used intraoperatively as an adjunctive monitor of haemoglobin oxygen saturation in superficial tissue.
Technology
The system includes a hyperspectral camera with a snapshot hyperspectral imaging sensor, a computational workstation running deep learning software for super-resolution and reconstruction, a camera control unit, and accessories such as surgical telescopes. It provides simultaneous RGB and tissue oxygenation imaging at video rates, leveraging AI-powered algorithms for real-time image reconstruction from multiplexed spectral data without ionizing radiation.
Performance
The device was validated through bench and GLP-compliant animal studies comparing StO2 measurement performance against a gold standard dissolved oxygen meter and reference devices. Imaging spatial resolution and RGB reconstruction were tested with standardized targets, demonstrating satisfactory performance. AI validation showed improved reconstruction metrics and generalizability. Animal studies confirmed safety, performance, usability, and clinical equivalence to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/30/2025
4 months - 2
FDA Approval
6/24/2025
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