Spectrawave

SpectraWAVE, founded in 2017 and based in Bedford, Massachusetts, is a medical imaging company focused on improving treatment and outcomes for patients with coronary artery disease (CAD). The company's flagship product is the HyperVue Imaging System, an intravascular imaging system that received FDA 510(k) clearance in March 2023. HyperVue combines next-generation DeepOCT (optical coherence tomography) images and near-infrared spectroscopy (NIRS) to optimize coronary stenting procedures in cardiac catheterization labs.

The HyperVue system utilizes SpectraWAVE's proprietary DeepOCT-NIRS imaging technology, which pushes the limits of optical coherence tomography in both image quality and depth. It features the Starlight Imaging Catheter, a low-profile, no-flush device that delivers rapid pullbacks of both imaging modalities in a single form factor. The system is designed to provide key insights into plaque morphology, guide plaque modification decisions, assist with stent and balloon sizing, and help with landing zone selection.

In September 2023, SpectraWAVE received additional FDA 510(k) clearance for enhancements to the HyperVue system. These include contrast-free saline imaging, artificial intelligence algorithms to support the identification of key clinical structures such as calcium and external elastic lamina, and hands-free angiographic co-registration. The system also incorporates AI-enabled lipid, lumen, stent, and side branch detection.