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EBR Systems Inc (ASX:EBR) – which is developing the world’s only wireless cardiac pacing device for heart failure – has ticked off another important step in its progress towards entering the US$3.6 billion US market, submitting its final Premarket Approval (PMA) module to the US Food and Drug Administration. And given the usual FDA review cycle parameters, the company anticipates approval of its WiSE CRT (Cardiac Resynchronization Therapy) System to be granted in the first quarter of CY2025, for a commercial launch sometime in the same year. Because WiSE has been designated a ‘Breakthrough Dev…

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