EBR Systems (ASX:EBR) said that its WiSE cardiac resynchronization therapy system was implanted in the first commercial patients in the US, following approval from the Food and Drug Administration, according to a Friday Australian bourse filing.
Reimbursement add-on payments for both inpatients and outpatients are expected to begin in October, the filing said.
The initiation of its limited market release is also expected in October, running into 2026, aimed at developing clinician advocacy and facilitating wider adoption.