Acumen Hypotension Prediction Index (HPI) Algorithm

Acumen Hypotension Prediction Index (HPI) Algorithm is an FDA 510(k)-cleared medical device (K230057) 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 June 7, 2023. Regulation: 8.