EBR Systems, Inc. (ASX:EBR) Schedules FDA Pre-Approval Inspection
FDA Inspection Scheduled
EBR Systems, Inc. (ASX: EBR) has scheduled its Pre-Approval Inspection (PAI) with the U.S. Food and Drug Administration (FDA) for the week commencing 6 January 2025. This marks a significant step in the regulatory process for its wireless cardiac pacing device, the WiSE® CRT System, designed for heart failure treatment.
Regulatory Milestones
The PAI follows the FDA’s initiation of the substantive review process for EBR’s Pre-Market Approval (PMA) submission in late September 2024. EBR also anticipates a Day-100 Meeting with the FDA on 20 December 2024. The PAI’s goal is to verify the compliance of EBR’s manufacturing and packing procedures with Quality System regulations, ensuring the consistent production of devices that meet approved specifications.
Executive Comment
EBR Systems emphasised that the FDA indicated an onsite Biomedical Monitoring (BIMO) audit is likely not required prior to final approval.
Future Outlook
The scheduling of the PAI continues to support EBR’s advancement in obtaining market clearance for the WiSE® CRT System, which holds the Breakthrough Device designation, allowing for expedited review. This ongoing regulatory journey is crucial for the future commercialisation of the WiSE® technology, which aims to improve cardiac pacing outcomes.
Motley Fool contributor Lianne Eastty has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.
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