EBR Systems Advances Towards 2025 U.S. Launch
EBR Systems, Inc. Shs Chess Depository Interests Repr 1 Sh (AU:EBR) has released an update.
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EBR Systems, Inc., a pioneer in wireless cardiac pacing technology, has successfully completed its Day-100 PMA meeting with the FDA, keeping its timeline for FDA approval and U.S. commercial launch on track for 2025. This milestone is part of the regulatory process for their innovative WiSE® CRT System, which is designed to improve heart failure treatment by eliminating external pacing leads. The company’s breakthrough device designation allows for prioritized review and interactive communication with the FDA, streamlining the path to market.
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