Latest Heart Failure News

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.

Mesoblast has commercially launched Ryoncil in the US for pediatric acute GVHD, backed by a strong cash position and advancing multiple cell therapy programs.

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.

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.

Echo IQ confirms the material significance of its pre-submission FDA meeting for EchoSolv HF, marking a pivotal step toward US market entry and commercialisation.

Mesoblast Limited is set to launch Ryoncil®, the first FDA-approved MSC therapy for pediatric steroid-refractory acute graft-versus-host disease, backed by a recent $160 million financing that strengthens its commercial and clinical development efforts.

Mesoblast has secured FDA approval for Ryoncil®, the first mesenchymal stromal cell therapy for steroid-refractory acute graft versus host disease in children, while raising A$260 million to accelerate clinical trials and commercial rollout.

Echo IQ Limited has secured FDA clearance for its EchoSolv AS technology and appointed a US-based CEO, marking a pivotal shift towards commercialisation in the American healthcare market.

InteliCare advances its AI-driven platform deployment across multiple Hardi Aged Care sites, while expanding its commercial pipeline and enhancing product capabilities.

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.

Nyrada Inc. reports promising preclinical results for its lead drug NYR-BI03, showing an 86% cardioprotective effect, alongside a strong financial position bolstered by a AU$3.29 million capital raise. The company has submitted its Phase Ia clinical trial package, setting the stage for human testing.

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.