Spryte Medical announced its neuro Optical Coherence Tomography (nOCT) technology has been granted Breakthrough Device Designation by the FDA. This recognition underscores the transformative potential of nOCT in neurointervention and cerebrovascular treatment, the company said in a press release.

This designation expedites the technology’s development and review process and supports reimbursement and timely access for patients and health-care providers, the company said.

In addition, Spryte Medical announced that it is pleased to be included in the FDA’s new Total Product Life Cycle Advisory Program (TAP), which aims to help speed development of high-quality, safe, effective and innovative medical devices that are critical to public health. According to the company, participation in the TAP program will provide Spryte with valuable feedback and support from the FDA, further accelerating the path to market for nOCT technology.

nOCT is specifically engineered for cerebrovascular navigation. This advanced intravascular imaging technology allows for detailed visualization of the brain's vascular anatomy at near histologic levels to provide improved diagnostic capabilities and enhance treatment precision.

By providing clinicians with detailed, real-time images of the brain’s vascular structures, nOCT is designed to enable more precise interventions, potentially improving patient outcomes and advancing our understanding of cerebrovascular diseases, the company said.