Spryte Medical's nOCT Technology Receives Breakthrough Device Designation from FDA

Spryte Medical announced that its Neuro Optical Coherence Tomography (nOCT) technology has been awarded Breakthrough Device Designation by the FDA. This designation highlights the potential of nOCT to revolutionize neurointervention and cerebrovascular treatment.

FDA Breakthrough Device Designation

The FDA's Breakthrough Device Designation is reserved for technologies that offer significant advantages over existing alternatives in diagnosing or treating life-threatening or irreversibly debilitating conditions. This status not only underscores the transformative potential of nOCT but also accelerates its development and review process. It also facilitates reimbursement and timely access for both patients and healthcare providers.

In addition to the Breakthrough Device Designation, Spryte Medical will be included in the FDA's new Total Product Life Cycle Advisory Program (TAP). This program aims to fast-track the development of high-quality, safe, and innovative medical devices that are critical to public health. TAP participation will provide Spryte with essential feedback and support from the FDA, further hastening the path to market for nOCT technology.

Advancements in Neurointervention

According to Spryte, Neuro Optical Coherence Tomography (nOCT) represents a major advancement in neurointervention. Unlike traditional intravascular imaging systems primarily designed for cardiology, nOCT is specifically engineered for cerebrovascular navigation. This advanced imaging technology offers detailed visualization of the brain's vascular anatomy at near histologic levels, enhancing diagnostic capabilities and treatment precision.

Expert Endorsement

"Neurointervention has had an incredibly positive impact on the treatment of cerebrovascular conditions. nOCT intravascular imaging will allow us to advance the field even further. With this technology we will be able to better visualize disease and devices, guide our decision-making, and deliver even better patient care," said Demetrius Lopes, medical director of the cerebrovascular and neuroendovascular program at Advocate Health, in a company news release.

"I have followed the development of intravascular imaging in cardiology for many years. I always believed that OCT information could have an even greater impact in neurointervention outcomes and I am excited to bring the benefits of this technology into the brain for the first time ever. Spryte nOCT was developed specifically with neurointervention in mind and has the potential to overcome the many limitations that prevented its use in the neurovasculature previously. The initial nOCT clinical experience demonstrated consistently the ease of use, safety, and imaging quality. This is a dream coming true… our patients will benefit the most."