TETmedical, Inc. has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its NSE-FAST® (Neuron Specific Enolase – Functional Activity Stroke Test), a rapid blood-based diagnostic assay developed to support the diagnosis of acute ischaemic stroke.
The designation highlights the technology's potential to improve the early detection of one of the most common and serious neurological emergencies.
NSE-FAST® measures the functional activity of neuron-specific enolase (NSE) in blood plasma using the company's patented Tethered Enzyme Technology (TET).
The test is designed to complement existing clinical assessments by providing additional diagnostic information for adults presenting with symptoms of acute ischaemic stroke.
Stroke affects approximately 840,000 people in the United States each year, with nearly 87 per cent of cases classified as ischaemic strokes.
While CT imaging can effectively identify haemorrhagic stroke, diagnosing acute ischaemic stroke remains challenging, creating a need for faster and more accurate diagnostic tools.
The FDA's Breakthrough Devices Programme offers developers enhanced regulatory support and more frequent interactions with the agency to accelerate the development and review process for innovative medical technologies.
TETmedical plans to launch a multi-centre pivotal clinical study in the fourth quarter of 2026, complete patient enrolment in 2027, and submit its FDA marketing application by the end of the same year.
The designation does not guarantee future FDA clearance or commercial authorisation.
