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EBR Systems Confirms Isolated Serious Complications With WiSE Cardiac Device
9:11am on Friday 31st of July, 2026 AEST
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Healthcare
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EBR Systems Confirms Isolated Serious Complications With WiSE Cardiac Device
9:11am on Friday 31st of July, 2026 AEST
Key Points
Two patients suffered ventricular fibrillation post-implant
One patient died; incidents confined to a single site
Events linked to known ultrasound-induced stimulation risk
FDA to review using EBR’s investigation and site data
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