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EBR Systems Boosts WiSE Production with ISO-Certified Facility and FDA Approval in Sight

9:20am on Monday 7th of September, 2026 AEST Healthcare
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EBR Systems Boosts WiSE Production with ISO-Certified Facility and FDA Approval in Sight

9:20am on Monday 7th of September, 2026 AEST
Key Points
  • Santa Clara facility achieves ISO 13485 certification
  • Automated assembly to increase WiSE production capacity by 500%
  • FDA Pre-Approval Inspection scheduled for September 2026
  • Facility supports US commercial scale-up of WiSE System
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