Spryte Medical neuro OCT receives Breakthrough Device Designation by FDA

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Spryte Medical has announced its neuro optical coherence tomography (nOCT) technology has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA).

According to the company, nOCT is specifically engineered for cerebrovascular navigation. This allows for detailed visualization of the brain's vascular anatomy which can provide improved diagnostic capabilities and enhance treatment precision.^1,2

Furthermore, according to the company nOCT allows visualization past the arterial lumen, through the arterial wall and even into the perivascular space. It allows for high-resolution imaging using backscattered light to produce cross-sectional images of biological tissue with micro-meter resolution.²

In addition to the nOCT designation, Spryte Medical also announced it has been included in the FDA’s Total Product Life Cycle Advisory Program (TAP). TAP is a program that aims to “help speed development of high-quality, safe, effective, and innovative medical devices that are critical to public health.” According to the company, being included in TAP will help provide valuable support and feedback from the FDA, which will “further accelerate the path to market for nOCT technology.”¹

Demetrius Lopes, MD, commented on the designation in a press release from Spryte.

“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. I have followed the development of intravascular imaging in cardiology for many years,” said Lopes.

References:

1. Spryte Medical Receives Breakthrough Device Designation from FDA for Revolutionary neuro Optical Coherence Tomography (nOCT) Technology. Press release. Released July 22, 2024. Accessed July 22, 2024. https://www.businesswire.com/news/home/20240722486759/en/Spryte-Medical-Receives-Breakthrough-Device-Designation-from-FDA-for-Revolutionary-neuro-Optical-Coherence-Tomography-nOCT-Technology

2. Spryte Medical. Accessed July 22, 2024. https://sprytemedical.com/