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EBR gains FDA alignment for WiSE safety labelling update
8:37am on Wednesday 16th of September, 2026 AEST
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Medical Devices
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EBR gains FDA alignment for WiSE safety labelling update
8:37am on Wednesday 16th of September, 2026 AEST
Key Points
FDA alignment on proposed labelling pathway
CBE PMA supplement planned for Q4 2026
Echo-induced pacing risks to receive greater prominence
No complication frequency or severity disclosed
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