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FDA-listed AI/ML-enabled medical devices

Devices the FDA identifies as using artificial intelligence or machine learning, with the regulators each one is registered with.

1,255 devices · when each source was last refreshed

Registers: US (FDA) · UK (MHRA) · CA (Health Canada) · AU (TGA) · EU (EUDAMED)

Device
ZEUS System (Zio Watch)

iRhythm Technologies, Inc.

Registered with
  • US (FDA)
Zio AT ECG Monitoring System, ZEUS System

iRhythm Technologies, Inc.

Registered with
  • US (FDA)
Zio ECG Utilization Software (ZEUS) System

iRhythm Technologies, Inc.

Registered with
  • US (FDA)
Ziostation2

Ziosoft, Inc.

Registered with
  • US (FDA)
  • AU (TGA)
Zio XT ECG Monitoring System, Zio AT ECG Monitoring System

iRhythm Technologies, Inc.

Registered with
  • US (FDA)