Spryte Medical has achieved a significant milestone with its neuro-optical coherence tomography (nOCT) technology being granted breakthrough device designation by the US Food and Drug Administration (FDA). This revolutionary technology is poised to revolutionize the field of neurointervention with its advanced imaging capabilities, user-friendly interface, and enhanced safety features.
The nOCT technology represents a substantial advancement in the imaging of the brain’s vascular structures, offering high-resolution imaging to enhance diagnostic accuracy and enable more precise treatments. This holds great promise for improving outcomes for patients in need of cerebrovascular care.
The FDA’s decision to bestow breakthrough device designation is a crucial validation of the potential impact of nOCT in the medical field. This designation aims to expedite the development and review process for innovative medical devices, ultimately leading to faster access for patients and healthcare providers. It also provides support for reimbursement strategies, further facilitating the adoption of this cutting-edge technology.
In addition to the breakthrough device designation, Spryte Medical has also been chosen to participate in the FDA’s Total Product Life Cycle Advisory Program (TAP), which provides valuable guidance to enhance the quality and safety of innovative medical devices. This inclusion demonstrates the FDA’s commitment to supporting the development of nOCT and ensuring its successful integration into clinical practice.
As part of the TAP programme, Spryte Medical will have the opportunity to receive direct feedback and support, accelerating the journey of nOCT to the market. This collaborative approach aligns with the company’s commitment to driving innovation in healthcare and improving patient outcomes.
CEO David Kolstad expressed enthusiasm about the potential impact of Spryte Medical’s neuro OCT imaging platform, stating, “Our engagement with the FDA through the breakthrough device and TAP, highlights the potential of Spryte Medical’s neuro OCT imaging platform for patients with cerebrovascular disease. We look forward to working collaboratively with the FDA for the benefit of these patients.”
The nOCT imaging probe, integrated into a standard neurovascular workflow, utilizes a micro-optical fibre to enter the brain’s arteries, enabling internal imaging. This innovative platform consists of an optical module, an AI-powered console, and a specialized fibre-optic neuroendovascular probe designed to navigate the brain’s intricate vasculature.
Spryte Medical’s groundbreaking nOCT technology represents a significant leap forward in the field of neurointervention, offering new possibilities for the diagnosis and treatment of cerebrovascular disease. The company’s commitment to collaboration with regulatory authorities and dedication to advancing patient care positions it as a leader in the development of innovative medical technologies.