AI-Enabled Medical Devices Listed in the ARTG

AI-Enabled Medical Devices Listed in the ARTG

04 Sep 2025

The Therapeutic Goods Administration (TGA) has published a list of medical devices in the Australian Register of Therapeutic Goods (ARTG) that use artificial intelligence (AI) or machine learning (ML) technologies.

This list was created in response to stakeholder requests for more transparency about how AI is used in medical devices.

The list was compiled using search criteria based on:

  • Terms in the product name or intended purpose

  • Devices where the use of AI or ML has been reported by the sponsor after March 2025

Note: The list may not include all AI- or ML-enabled medical devices currently registered.

Sponsors of AI-enabled devices who want their product included can contact: Digital.Devices@tga.gov.au.

You can review the list of AI-enabled medical devices in the ARTG here.

Source: Therapeutic Goods Administration (TGA), Australian Government

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