Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform

Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform is an FDA 510(k)-cleared medical device (K203224) 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 July 29, 2021. Regulation: 8.