Latest Medical Devices News

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.

EMVision Medical Devices has enhanced its AI-powered stroke diagnostic algorithm, achieving a notable 95% sensitivity and 80% specificity in recent tests. This progress sets the stage for upcoming pivotal trials and regulatory milestones.

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.

Anteris Technologies has submitted its FDA Investigational Device Exemption for the pivotal PARADIGM Trial of its DurAVR heart valve and marked a milestone of 100 patients treated, while expanding manufacturing capacity amid rising R&D costs.

Anteris Technologies Global Corp. reported a $21.9 million net loss for Q1 2025, driven by increased R&D spending as it scales manufacturing and prepares pivotal trials for its DurAVR Transcatheter Heart Valve. The company’s recent $80 million IPO proceeds are being deployed to support these efforts and repay debt.

PolyNovo has secured Therapeutic Goods Administration clearance for thicker versions of its NovoSorb MTX product, broadening treatment options for complex wounds in Australia.

Universal Biosensors reports solid growth in its wine testing segment and outlines plans for a capital raise alongside the upcoming AQUASCOUT water testing device launch.

ResMed Inc has updated the foreign exchange rate for its upcoming dividend payable to ASX-listed CDI holders, impacting the Australian dollar equivalent of the payout.

AVITA Medical reveals a bold expansion plan targeting a $3.5 billion U.S. acute wound care market by 2025, driven by a multi-product portfolio and sustained revenue growth.

AVITA Medical reported a robust 67% increase in first quarter 2025 revenue, driven by new product launches and a strategic commercial overhaul, while reaffirming its full-year growth and profitability targets.

Cardiex Limited has formally lodged its CONNEQT Pulse device with Australia's Therapeutics Goods Administration, marking a critical step toward regulatory approval and market expansion.

Imricor Medical Systems has initiated its first MRI-guided atrial flutter ablation procedures at Semmelweis University in Budapest, marking a significant expansion of its real-time MRI technology in Europe.