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EBR takes WiSE heart failure device into Australia’s priority review pathway
9:00am on Tuesday 20th of October, 2026 AEDT
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Medical Devices
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EBR takes WiSE heart failure device into Australia’s priority review pathway
9:00am on Tuesday 20th of October, 2026 AEDT
Key Points
TGA application submitted for WiSE inclusion on the ARTG
April 2026 Priority Review Determination expected to shorten the target evaluation period
Potential Australian market entry for patients who have not benefited from conventional CRT
FDA approval supports the application, but TGA approval remains outstanding
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