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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 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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