Address: 12 Oak Park Dr. Bedford, MA 01730
Released:3/20/2025
Regulator:FDA
The Starlight Imaging Catheter is a sterile, single-use catheter designed for imaging coronary arteries in patients undergoing transluminal interventional procedures. It uses near-infrared light and an internal rotating fiber optic core to capture detailed cross-sectional images inside vessels, helping clinicians assess vessel condition and guide interventions safely and effectively.
View detailsReleased:7/16/2025
Regulator:FDA
HyperVue™ Software is an imaging system that uses Optical Coherence Tomography (OCT) technology to produce detailed images of cardiovascular structures. It helps clinicians by providing high-resolution images that assist in diagnosing and treating cardiovascular diseases.
View detailsReleased:10/17/2025
Regulator:FDA
The X1-FFR by SpectraWAVE, Inc. is a software tool that uses X-ray angiographic images to simulate coronary vascular conditions, helping clinicians assess coronary artery disease noninvasively.
View detailsReleased:12/15/2025
Regulator:FDA
The HyperVue Imaging System - Integrated by Spectrawave, Inc. is an Optical Coherence Tomography (OCT) system designed for cardiovascular imaging. It helps clinicians visualize inside blood vessels with high resolution to aid diagnosis and treatment planning.
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