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Edwards Lifesciences Granted De Novo Request for Acumen HPI Software

March 19, 2018

The FDA granted Edwards Lifesciences its De Novo request for the company’s Acumen Hypotension Prediction Index (HPI) software, technology that uses predictive analytics to indicate the presence of potential low blood pressure before it occurs in surgical patients.

The Acumen HPI uses software algorithms to assess cardiovascular vital signs and predict future cardiovascular status, and is only compatible with Edwards’ minimally invasive, hemodynamic monitoring solutions.

The HPI feature is part of the Edwards Accumen intelligent decision-support software suite and is used with the minimally invasive FloTrac IQ sensor.

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