Neuralert Technologies’ Neuralert Monitor Designated a Breakthrough Device

The FDA has granted breakthrough device status to Neuralert Technologies’ Neuralert monitor, designed to detect early signs of stroke.

The device is indicated to “detect the onset of asymmetric movement in hospitalized patients with medical conditions or procedures that are established risks for stroke,” the Philadelphia-based University of Pennsylvania spinoff said.

The monitor, which uses noninvasive, wearable components, automatically alerts clinical staff when it detects a problem, resulting in more rapid assessment and treatment.