Posted by Michael Wonder on 03 Mar 2021
FDA grants de novo to ML-based, real-time indicator of patient deterioration
2 March 2021 - Fifth Eye's non-invasive tool is the first to provide continuous monitoring of haemodynamic status using a single ECG lead.
Fifth Eye today announced the U.S. FDA has granted De Novo classification for its Analytic for Hemodynamic Instability (AHI). AHI can continuously monitor any patient with an electrocardiogram for haemodynamic instability — a leading cause of death for critically ill or injured patients. This clinically validated technology enables haemodynamic assessments every two minutes as opposed to every two hours or more, increasing the likelihood of timely patient rescue.
