FDA clears Edwards Lifesciences hypotension index software

Edwards Lifesciences (NYSE:EW) said today it won FDA de novo approval for its Acumen Hypotension Prediction Index software designed to address potential hypotension in surgical patients. The Irvine, Calif.-based company said it is engaging in a targeted launch of the system in the US following the approval, which clears the software as an adjunctive predictive cardiovascular indicator. “The Acumen Hypotension Prediction Index is a next-generation, predictive monitoring software that represents the future of how we can use patient data to improve healthcare. HPI improves patient care by providing intelligent decision support, moving beyond descriptive monitoring to facilitate predictive monitoring, which provides more clarity on a patient’s condition to enable clinicians to make more proactive decisions,” Edwards critical care corp. VP Catherine Szyman said in a press release. The HPI software uses algorithms to analyze cardiovascular vital signs to predict future events and cardiovascular status, Edwards said. The system is only compatible with Edwards hemodynamic monitoring solutions. Analytics within the HPI are powered by a data driven model developed from more than 200,000 patient events. The system includes the HPI software, an alarm to alert when the HPI exceeds the upper threshold and a secondary screen to link blood pressure and hemodynamic flow parameters to identify causes of low blood pressure, the company said. “Even brief periods of hypo...
Source: Mass Device - Category: Medical Devices Authors: Tags: Blood Management Food & Drug Administration (FDA) Regulatory/Compliance Software / IT Edwards Lifesciences Source Type: news