FDA awards Neuralert Technologies Breakthrough Device Designation
Philadelphia, PA –The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has granted the Neuralert Monitor designation as a Breakthrough Device. The Neuralert Technologies device is indicated for use to “detect the onset of asymmetric movement in hospitalized patients with medical conditions or procedures that are established risks for stroke and who have no baseline asymmetric upper extremity weakness.”
Neuralert is a spin-out from the University of Pennsylvania, founded by Steven Messé, MD (Department of Neurology) and James Weimer, PhD (Department of Computer and Information Science). The company’s novel invention addresses the problem of late or undetected stroke in hospitalized patients. The system uses non-invasive, wearable devices which continuously monitor at-risk hospitalized patients for stroke symptoms and automatically alerts clinical staff resulting in more rapid assessment and treatment of the patient. Neuralert’s automated detection process may be up to ten times faster when compared to the current standard of care which relies on manual detection processes. Reduction in stroke detection time will save patient lives, improve outcomes, and reduce hospital cost and liability.
“Currently, hospital stroke detection requires consistent, timely, and effective manual assessment. Unfortunately, the majority of in-hospital strokes are not detected in a timely manner resulting in treatment delays which adversely impact patient outcomes and hospital cost” said Eric Corkhill, CEO of Neuralert. “Neuralert is an automated stroke symptom detection system which constantly monitors the patient for stroke-based asymmetry, a revolutionary change in managing stroke. FDA granting Neuralert Breakthrough Device designation is a major milestone in our efforts to bring this valuable and revolutionary technology to market.”
About Neuralert Technologies: Founded in 2019, as a spinout from the University of Pennsylvania, Neuralert’s mission is to transform the method of monitoring for stroke symptoms in hospitalized patients. By combining lightweight, non-invasive wearable devices with a patented algorithm, the Neuralert system constantly monitors patients for stroke symptoms and automatically alerts hospital staff when detected, speeding treatment which saves lives and improves outcomes. Neuralert Technologies is headquartered in Philadelphia, Pennsylvania. For more information, please visitwww.neuralerttechnologies.com.
