Spryte Medical has received the breakthrough device designation from the US Food and Drug Administration (FDA) for its neuro optical coherence tomography (nOCT) technology.
The Massachusetts-based medical imaging technologies company has designed the nOCT technology for neurointervention and cerebrovascular treatment.
The technology is said to offer more imaging clarity, safety, and user-friendliness during neurointervention procedures.
nOCT aims to enhance the precision of interventions by providing clinicians with real-time, intricate images of cerebral vascular structures.
The technology potentially elevates patient outcomes and deepens insights into cerebrovascular conditions.
According to Spryte Medical, the FDA’s breakthrough device status acknowledges the potential impact of nOCT. The designation will also accelerate its development and review processes, facilitate reimbursement, and ensures timely access for patients and healthcare providers.
Concurrently, Spryte Medical has participated in the FDA’s new Total Product Life Cycle Advisory Program (TAP), aimed at expediting the development of safe and effective, medical devices crucial to public health.
The inclusion in the TAP programme will grant Spryte Medical with FDA’s feedback and support, which will further accelerate the journey to market for the nOCT technology.
According to Spryte Medical, the nOCT technology represents a significant advancement in neurointervention.
Unlike conventional intravascular imaging systems primarily designed for cardiology, nOCT is specifically tailored for cerebrovascular navigation, said the company.
The intravascular imaging technology provides high-resolution visualisation of the brain’s vascular anatomy, approaching histologic detail. This advancement improves diagnostic accuracy and treatment effectiveness.
Spryte Medical’s technology can be integrated into established procedural workflows. This will make it as the first and only intracranial imaging technology globally available to clinicians.
It enables both intraluminal imaging and volumetric microscopy of neurovascular vessels, the medical imaging technologies firm said.
Spryte Medical CEO David Kolstad said: “Our engagement with the FDA through the Breakthrough Device and Total Product Life Cycle Advisory Program (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.”
