Acumen Hypotension Prediction Index (HPI) Feature Software

Acumen Hypotension Prediction Index (HPI) Feature Software is an FDA 510(k)-cleared medical device (DEN160044) manufactured by Edwards Lifesciences, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 15, 2018. Regulation: 8.