Spryte Medical has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its neuro-optical coherence tomography (nOCT) technology.
Designed to revolutionise the field of neurointervention, the technology offers enhanced imaging quality, ease of use and safety.
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The nOCT technology is equipped to provide high-resolution imaging of the brain’s vascular structures.
This allows for improved diagnostic accuracy and the possibility of more precise treatments, which could lead to better patient outcomes in cerebrovascular care.
The FDA’s breakthrough device designation facilitates the development and expedited review of nOCT, potentially leading to faster patient and healthcare provider access. It also supports reimbursement strategies.
Additionally, Spryte Medical has been included in the FDA’s Total Product Life Cycle Advisory Program (TAP), which offers guidance to enhance the quality and safety of innovative medical devices.
Being part of the programme will allow Spryte Medical to receive direct feedback and support, accelerating nOCT’s journey to the market.
Spryte Medical CEO David Kolstad said: “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.”
Using a standard neurovascular workflow, the Spryte nOCT imaging probe utilises a micro-optical fibre to enter the brain’s arteries, enabling internal imaging.
This platform features an optical module, an AI-powered console, and a specialised fibre-optic neuroendovascular probe designed to navigate the brain’s intricate vasculature.
