NEWS | Sep 4, 2025

Sense Neuro Diagnostics Submits FDA Application for NeuroHawk, A Breakthrough in Rapid Stroke and TBI Detection

Cincinnati, OH —  Sense Neuro Diagnostics, a leader in non-invasive neurodiagnostic technology, announced today that it has formally submitted its NeuroHawk™ system to the U.S. Food and Drug Administration (FDA) for regulatory clearance. NeuroHawk™ is a breakthrough rapid, radio-frequency–based platform designed to detect and monitor brain bleeds, stroke, and traumatic brain injury in under four minutes at the point of care, including in ambulances, emergency departments, intensive care units, and military environments.

Unlike current diagnostic methods that rely on CT or MRI imaging, NeuroHawk™ provides real-time assessment at the patient’s side. The system combines a reusable control unit with a single-use disposable headset, creating a scalable solution that can help emergency and hospital providers make faster, more accurate triage decisions in time-critical neurological emergencies.

“Submission of NeuroHawk™ to the FDA represents a defining moment for Sense Neuro and for the millions of patients who suffer from stroke and traumatic brain injury each year,” said Gary Kurdziel, MBA, Chief Executive Officer of Sense Neuro Diagnostics. “By empowering first responders and clinicians with real-time brain data, NeuroHawk™ has the potential to transform neurocritical care by enabling faster, more accessible diagnosis, improving patient outcomes, reducing disability, and easing the burden on families and healthcare systems. We are proud of the progress our team has made and look forward to collaborating with the FDA to bring this life-saving technology to market.”

Opeolu Adeoye, MD, Chief Medical Officer of Sense Neuro Diagnostics and a national leader in stroke and TBI research, added:

“The ability to detect brain bleeds in the field, within minutes, represents a paradigm shift in emergency neurocritical care. NeuroHawk could give providers a head start on life-saving treatment decisions before patients even reach the hospital.”

NeuroHawk™ has undergone extensive clinical testing in collaboration with leading medical centers, emergency service providers, and multi-site Department of Defense–funded trials. The FDA submission reflects years of innovation and validation by Sense Neuro’s multidisciplinary team, uniting expertise in medical device engineering, neuroscience, and emergency medicine.