SpectraWAVE Secures 510(k) Clearance of HyperVue Intravascular Imaging System

SpectraWAVE, a medical imaging company focused on improving the treatment and outcomes for patients with coronary artery disease (CAD), announced Food and Drug Administration (FDA) 510(k) clearance of their flagship intravascular imaging system, HyperVue The system combines next-generation DeepOCT images and near infrared spectroscopy (NIRS) with state-of-the-art ease of use to support physicians optimizing coronary stenting in the cardiac catheterization lab. In addition, the system has now been used by multiple physicians as part of a first-in-human study. "Clinical evidence strongly suggests that patients benefit from intravascular imaging-guided stent optimization" "This is a landmark day for SpectraWAVE, but more importantly, a critical step towards improving outcomes for patients with coronary artery disease," said Eman Namati, Ph.D., Chief Executive Officer of SpectraWAVE. "Our proprietary DeepOCT-NIRS imaging system pushes the technological limits of optical coherence tomography--both in image quality and depth--while combining it with spectroscopy for the first time, packaging both into a no-flush catheter with an artificial intelligence-powered user experience. With this regulatory clearance, we are excited to begin the transition to a commercial entity and launch our product."