Spryte Medical Receives Breakthrough Device Designation from FDA for Neuro OCT Technology
Spryte Medical announced that its neuro Optical Coherence Tomography (nOCT) technology has been granted Breakthrough Device Designation by the FDA. This recognition underscores the potential of nOCT in neurointervention and cerebrovascular treatment.
The FDA’s Breakthrough Device Designation is awarded to technologies that offer advantages over existing alternatives in treating or diagnosing life-threatening or irreversibly debilitating diseases. This designation not only recognizes the potential revolutionary impact of nOCT but also expedites its development and review process, supports reimbursement and timely access for patients and healthcare providers.
Spryte Medical also announced it will 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. 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.
Neuro Optical Coherence Tomography (nOCT) represents a significant leap forward in neurointervention, according to Spryte. Unlike traditional intravascular imaging systems designed primarily for cardiology, 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.
"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," Demetrius Lopes,medical director of the cerebrovascular and neuroendovascular program at Advocate Health, said 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."
For more information about Spryte Medical and its nOCT technology, visit www.sprytemedical.com.