Latest Regulatory Approvals News

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EBR Systems Confirms FDA Inspection Delay but Keeps Q1 Approval on Track

EBR Systems has announced a rescheduling of the FDA Pre-Approval Inspection for its wireless cardiac pacing device to January 14, 2025, while maintaining its regulatory approval timeline for Q1 2025 and a commercial launch later in the year.

Ada Torres

6 Jan 2025

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