Articles from Spryte Medical

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.

Spryte Medical, a pioneering company in advanced medical imaging technologies, proudly announces that its neuro Optical Coherence Tomography (nOCT) technology has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). This recognition underscores the transformative potential of nOCT in neurointervention and cerebrovascular treatment.

Spryte Medical, an intravascular imaging and AI company today announced the publication of their first-in-human study of its neuro Optical Coherence Tomography (nOCT) technology in the peer reviewed journal Science Translational Medicine, entitled “Volumetric microscopy of cerebral arteries with a miniaturized optical coherence tomography imaging probe.” This research, hailed as a significant milestone by researchers, is the first to demonstrate the ability to bring intravascular imaging to the brain, helping clinicians to better see the pathology associated to neurovascular disease, with potential future implications for the treatment of stroke and related conditions.