EBR Systems, Inc. (ASX:EBR) Completes FDA Pre-Approval Inspection
Key Achievements
EBR Systems, Inc. (ASX: EBR) has completed the U.S. Food and Drug Administration (FDA) manufacturing Pre-Approval Inspection (PAI) without any Form FDA 483 observations. This successful conclusion is a significant milestone towards obtaining regulatory approval for their wireless cardiac pacing device.
Regulatory Timeline
The PAI, conducted between 14 and 17 January 2025, verified that EBR’s manufacturing processes comply with Quality System regulations. Based on typical review times, EBR anticipates receiving regulatory approval on or before 13 April 2025, with a commercial launch expected in the second half of 2025.
CEO’s Commentary
John McCutcheon, President and Chief Executive Officer of EBR Systems, expressed satisfaction with the outcome, stating, “These audits are very rigorous, and the result is a clear indication of our team’s commitment to following good manufacturing practices.” He added that the favourable PAI outcome allows the company to tighten its FDA approval expectations.
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