The Latest Cardiac and Vascular News
FDA-approved IDE trial to evaluate the safety and effectiveness of the nOCT™ Imaging System to provide quality images for diagnostic assessment during endovascular intracranial aneurysm treatment and follow-up FDA-approved IDE trial to evaluate the safety and effectiveness of the nOCT™ Imaging System to provide quality images for diagnostic assessment during endovascular intracranial aneurysm treatment and follow-up
BEDFORD, Mass., Nov. 19, 2025 (GLOBE NEWSWIRE) — Spryte Medical, a pioneer in intravascular neuro imaging, announced it has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to initiate the INSYTE pivotal trial. The trial will evaluate the safety and effectiveness of Spryte’s neuro Optical Coherence Tomography (nOCT) imaging system for use during intracranial aneurysm treatment procedures.
