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EBR Systems, Inc. Shs Chess Depository Interests Repr 1 Sh ( (AU:EBR) ) has issued an update.
EBR Systems, Inc. announced that the FDA has scheduled its manufacturing Pre-Approval Inspection for its WiSE CRT System, the world’s only wireless cardiac pacing device, to begin on January 14, 2025. This inspection is crucial to ensure regulatory compliance and readiness for commercial launch, which remains on track for later in the year. The FDA’s Breakthrough Device designation for EBR’s system facilitates prioritized review, potentially enhancing the company’s market position and offering more reliable treatments for heart failure patients.
More about EBR Systems, Inc. Shs Chess Depository Interests Repr 1 Sh
Silicon Valley-based EBR Systems, Inc. is a company focused on advancing cardiac rhythm disease treatment with its groundbreaking WiSE technology, which offers wireless cardiac pacing to eliminate the need for traditional leads. Their primary product, the WiSE CRT System, targets heart failure patients requiring cardiac resynchronization therapy by providing a more physiologically effective stimulation of the heart’s left ventricle. The company is exploring future applications in bradycardia and other non-cardiac indications.
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