Latest Heart Failure News

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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
Echo IQ has initiated a pivotal clinical validation study with the Mayo Clinic Platform to test its EchoSolv HF software, marking the final step before its planned FDA submission in late 2025.
Ada Torres
Ada Torres
1 July 2025
Mesoblast has secured FDA agreement on key requirements for its Biologics License Application for Revascor, targeting ischemic heart failure patients with reduced ejection fraction. The company aims for accelerated approval by year-end 2025.
Ada Torres
Ada Torres
1 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
Mesoblast reports positive FDA progress on accelerated approval for Revascor in ischemic heart failure and plans a pivotal trial to extend Ryoncil’s label to adults with graft versus host disease, while its US commercial launch outpaces expectations.
Ada Torres
Ada Torres
12 June 2025
EBR Systems has completed the first commercial US implants of its FDA-approved WiSE wireless cardiac resynchronization therapy system, marking a pivotal step toward broader market adoption and reimbursement.
Ada Torres
Ada Torres
6 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
Mesoblast has been granted a seven-year orphan-drug exclusivity by the FDA for its cell therapy Ryoncil, reinforcing its market position in treating steroid-refractory acute graft versus host disease in children.
Ada Torres
Ada Torres
15 May 2025
InteliCare Holdings has secured a new commercial trial with mecwacare and advanced deployments at Hardi Aged Care sites, underpinning growth in its AI-driven aged care platform amid regulatory changes.
Victor Sage
Victor Sage
30 Apr 2025
Mesoblast has commercially launched Ryoncil in the US for pediatric acute GVHD, backed by a strong cash position and advancing multiple cell therapy programs.
Ada Torres
Ada Torres
30 Apr 2025
Echo IQ Limited marked a pivotal quarter with FDA clearance for EchoSolv AS, strategic US partnerships, and a clear path toward reimbursement and broader commercialisation.
Ada Torres
Ada Torres
29 Apr 2025
ImpediMed Limited has locked in a US$15 million growth capital facility with SWK Funding LLC, providing crucial financial flexibility to advance its SOZO Digital Health Platform and commercial ambitions.
Ada Torres
Ada Torres
6 Feb 2025