SpectraWAVE Secures FDA Clearance for Intravascular Imaging Tech
BEDFORD, Mass., March 14, 2023 — Medical imaging company SpectraWAVE has received 510(k) clearance from the Food and Drug Administration (FDA) for its intravascular imaging system, HyperVue. The dual modality system combines OCT and near-infrared spectroscopy (NIRS) to support physicians optimizing coronary stenting in the cardiac catheterization lab. Additionally, SpectraWave announced, the system has now been used by multiple physicians as part of a first in-human study. According to Eman Namati, CEO of SpectraWAVE,