The FDA’s breakthrough device designation facilitates the development and expedited review of the technology. Credit: Gorodenkoff / Shutterstock.

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.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

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.

See Also:

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.