AI devices with FDA product code PPW — Adjunctive Cardiovascular Status Indicator

Product code PPW (“Adjunctive Cardiovascular Status Indicator” in openFDA) covers 1 device on the FDA AI-enabled list, from 1 company. Most are reviewed by the Cardiovascular panel (1). The most recent decision was prolaio eVO2peak Module (Version 1.0) on December 16, 2025.