Across the country, many intensive care units are strained for capacity. This prolongs the boarding process in the emergency department, when critically ill patients – for whom every minute and hour is crucial – wait for open ICU beds.
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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 or injured patients. This clinically validated technology enables hemodynamic assessments every two minutes as opposed to every two hours or more, increasing the likelihood of timely patient rescue.