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EBR’s New Facility Reaches FDA Inspection Stage Ahead of Year-End Decision
9:24am on Tuesday 15th of September, 2026 AEST
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Medical Devices
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EBR’s New Facility Reaches FDA Inspection Stage Ahead of Year-End Decision
9:24am on Tuesday 15th of September, 2026 AEST
Key Points
FDA pre-approval inspection initiated at Santa Clara facility
EBR still expects facility approval by year-end
Inspection outcome remains the next regulatory milestone
WiSE is currently available for sale only in the US
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