The FDA has granted 510(k) clearance to Prolira’s DeltaScan Brain State Monitor bedside EEG to aid in diagnosing acute encephalopathy in hospitalized patients over 60 years of age.

The device, which measures polymorphic delta waves — a metric for detecting acute brain failure — even before symptoms occur, has demonstrated 85 percent accuracy in a study.

Every year, approximately 50 percent of surgical and intensive care unit patients in the U.S. and Europe are at risk of developing acute encephalopathy and delirium, and up to 88 percent of cases are missed, the company said.