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FDA Clears EBR’s WiSE System After Cybersecurity Review
9:26am on Wednesday 9th of September, 2026 AEST
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Medical Devices
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FDA Clears EBR’s WiSE System After Cybersecurity Review
9:26am on Wednesday 9th of September, 2026 AEST
Key Points
FDA agrees no WiSE System recall or field corrective action is warranted
Incident classified as Controlled Risk under FDA postmarket guidance
No identified impact on fielded device safety or performance
EBR continues cybersecurity remediation and product hardening
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