List of AI-enabled medical devices in the ARTG

We have published a list of medical devices in the Australian Register of Therapeutic Goods (ARTG) that incorporate artificial intelligence (AI) or machine learning (ML) technologies. This list was developed in response to stakeholder feedback requesting greater transparency about the use of AI in medical devices.

The list was generated using search criteria that identify terms in the product name or intended purpose, or where the use of AI or ML has been reported by the sponsor after March 2025. It may not include all registered medical devices that use AI or ML technologies.

Sponsors of AI-enabled medical devices listed in the ARTG who would like their device included should contact: Digital.Devices@tga.gov.au.

Review the list of AI-enabled medical devices in the ARTG.