AI devices with FDA product code DSI — Detector And Alarm, Arrhythmia
Product code DSI (“Detector And Alarm, Arrhythmia” 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 BodyGuardian Remote Monitoring System (BGRMS v3.0) on January 23, 2026.
2AI devices
2Companies
2020First decision
2026-01-23Latest decision
Trend: devices per year
20202026