AI devices with FDA product code QAQ — Adjunctive Predictive Cardiovascular Indicator

Product code QAQ (“Adjunctive Predictive Cardiovascular Indicator” in openFDA) covers 2 devices on the FDA AI-enabled list, from 2 companies. Most are reviewed by the Cardiovascular panel (2). The most recent decision was Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure on May 21, 2019.