Latest Cardiac Pacing News

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EBR Systems has secured final CMS approval for Transitional Pass-Through reimbursement for its WiSE CRT System, effective October 1, 2025, enhancing hospital adoption prospects in the U.S.
Ada Torres
Ada Torres
22 Sept 2025
EBR Systems has achieved a significant commercial milestone with its tenth US implant of the WiSE wireless cardiac pacing system, setting the stage for broader market adoption supported by new reimbursement schemes.
Ada Torres
Ada Torres
17 Sept 2025
EBR Systems has secured FDA approval for its pioneering leadless WiSE CRT System and obtained key Medicare reimbursement endorsements, setting the stage for its commercial rollout. The company also completed a significant capital raise to support its market expansion.
Ada Torres
Ada Torres
13 Aug 2025
EBR Systems has won final CMS approval for New Technology Add-On Payment reimbursement, paving the way for Medicare coverage of its innovative WiSE cardiac pacing system starting October 2025.
Ada Torres
Ada Torres
5 Aug 2025
EBR Systems has received preliminary approval from the U.S. Centers for Medicare & Medicaid Services for outpatient reimbursement of its WiSE® CRT System, marking a major step toward broader hospital adoption.
Ada Torres
Ada Torres
15 July 2025
EBR Systems has successfully completed a heavily oversubscribed Security Purchase Plan, raising a total of A$75.9 million alongside a prior institutional placement to fund its innovative wireless cardiac pacing technology through 2027.
Ada Torres
Ada Torres
18 June 2025
EBR Systems has raised A$55.9 million through a fully underwritten placement to fund the commercial rollout of its FDA-approved wireless cardiac pacing system, with plans for a limited market release in H2 2025 and expanded distribution in 2026.
Ada Torres
Ada Torres
22 May 2025
EBR Systems has won FDA approval for its pioneering leadless WiSE CRT System, setting the stage for a phased US commercial rollout. The company also secured key Medicare reimbursement pathways and expanded manufacturing capacity, though financial sustainability remains a concern.
Ada Torres
Ada Torres
14 May 2025
EBR Systems has signed a long-term lease for a 51,000 sq ft facility in Santa Clara, California, positioning itself for significant manufacturing expansion and future growth in wireless cardiac pacing technology.
Ada Torres
Ada Torres
28 Jan 2025
EBR Systems has announced a rescheduling of the FDA Pre-Approval Inspection for its wireless cardiac pacing device to January 14, 2025, while maintaining its regulatory approval timeline for Q1 2025 and a commercial launch later in the year.
Ada Torres
Ada Torres
6 Jan 2025