Latest Cardiac Pacing News

EBR Systems has submitted its WiSE wireless cardiac pacing system for Australian regulatory approval, opening a potential second commercial market after the United States. The application has entered a priority review pathway, but neither approval nor an assessment timetable is guaranteed.

EBR Systems reported 40 WiSE commercial implants in Q3, down from 46 in Q2 and below its prior forecast, as leadership changes and a sales strategy reset disrupted activity. Higher Medicare reimbursement and progress at its new manufacturing facility offer potential offsets, but both remain dependent on execution and regulatory approval.

EBR Systems has completed the FDA’s pre-approval inspection of its new Santa Clara manufacturing facility, receiving two Form 483 observations. The company says it expects to correct them in the fourth quarter and still anticipates approval by year-end, although the FDA has not yet made its final determination.

CMS has finalised higher Medicare inpatient reimbursement for EBR Systems’ WiSE System, lifting base payment rates by up to 93% from 1 October 2026. The change improves the commercial payment pathway, although its financial impact will depend on procedure volumes, hospital adoption and NTAP eligibility.

EBR Systems plans to file a Changes Being Effected PMA supplement in the fourth quarter to make echo-induced pacing risks and their mitigations more prominent on WiSE System labelling. The FDA has aligned with the proposed path, but the filing and final labelling changes are still ahead.

EBR Systems’ new Santa Clara manufacturing facility has entered the FDA’s pre-approval inspection process, marking a key regulatory step for its wireless cardiac pacing business. The company continues to expect approval by the end of 2026, but the inspection does not yet amount to clearance.

The FDA has agreed that EBR Systems’ WiSE cardiac pacing system does not require a field corrective action or recall following a February cybersecurity incident. The device maker says it has found no evidence of any impact on the safety or performance of fielded systems, while remediation work continues.

EBR Systems has secured ISO 13485 certification for its new Santa Clara manufacturing site, paving the way for a 500% increase in WiSE System production pending FDA approval expected by year-end.

EBR Systems advanced its wireless cardiac pacing rollout in Q2 2026, completing 46 implants and signing 17 new purchasing contracts while shifting focus to deeper utilisation within existing accounts.

EBR Systems has launched the WiSE Coupler in the US, a new accessory designed to improve the implantation of its wireless cardiac pacing electrode. The device has FDA clearance and was piloted in 10 procedures, marking another step in the company’s US commercial expansion.

EBR Systems has wrapped up the retail tranche of its fully underwritten entitlement offer, adding A$10.9 million to a total raise of about A$43.6 million to support its wireless cardiac pacing technology.

EBR Systems has kicked off a fully underwritten 1-for-2 entitlement offer priced at $0.38 per CDI, aiming to raise $85.6 million to accelerate commercialisation and manufacturing of its wireless cardiac pacing technology.