EBR Systems Submits TGA ARTG Application for WiSE System
Key points
- EBR Systems submitted application to TGA for WiSE System inclusion
- Expected to be assessed under Priority Review Determination
- Approval would expand commercial footprint to Australia
Full summary
EBR Systems, Inc. has submitted its application to the Therapeutic Goods Administration (TGA) for inclusion of the WiSE System on the Australian Register of Therapeutic Goods (ARTG). This application is a significant step in EBR's regulatory and commercialization strategy. The submission follows the TGA's grant of Priority Review Determination for the WiSE System in April 2026, which is expected to accelerate the evaluation process. If approved, the WiSE System would be available to Australian heart failure patients who have not responded to conventional therapies, offering them a leadless left-ventricular pacing option.
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