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EBR Systems Confirms FDA Inspection Delay but Keeps Q1 Approval on Track
9:17am on Monday 6th of January, 2025 AEDT
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Healthcare
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EBR Systems Confirms FDA Inspection Delay but Keeps Q1 Approval on Track
9:17am on Monday 6th of January, 2025 AEDT
Key Points
FDA Pre-Approval Inspection rescheduled to 14 January 2025
Regulatory approval timeline remains on track for Q1 2025
Commercial launch expected later in 2025
Inspection focuses on manufacturing compliance with Quality System regulations
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