News
TETmedical Receives FDA Breakthrough Device Designation for NSE-FAST®, the First Rapid Test Designed to Aid in the Diagnosis of Acute Ischemic Stroke
Overview
The FDA granted Breakthrough Device Designation to NSE-FAST® (Neuron Specific Enolase – Functional Activity Stroke Test), a rapid blood test from TETmedical, Inc. positioning them as the first rapid test to aid in diagnosing acute ischemic stroke.Stroke is the #1 condition tied to serious misdiagnosis harm in U.S. emergency departments with roughly 17% of strokes are missed. CT scans catch hemorrhagic strokes well but frequently miss acute ischemic ones. NSE-FAST® uses TETmedical’s patented Tethered Enzyme Technology (TET) to measure the functional enzymatic activity of NSE in blood plasma — requiring just one extra small tube of blood — as a biomarker to flag ischemic stroke faster.
The Big Picture
TETmedical emerged from Cornell University and is also in New York Venture’s Pre-Seed and Seed Fund portfolio demonstrating diagnostics as a strength in the Empire state.
