Press release content from PR Newswire. The AP news staff was not involved in its creation. FDA Grants De Novo to ML-based, Real-time Indicator of Patient Deterioration March 2, 2021 GMT ANN ARBOR, Mich., March 2, 2021 /PRNewswire/ -- Fifth Eye TM, a provider of intuitive real-time clinical analytics, today announced the U.S. Food and Drug Administration (FDA) has granted De Novo classification for its Analytic for Hemodynamic Instability (AHI). AHI can continuously monitor any patient with an electrocardiogram (ECG) for hemodynamic instability — a leading cause of death for critically ill ...