Latest Medical Devices News

ReNerve Limited has gained marketing approval for its NervAlign® Nerve Cuff™ in Bahrain, marking its first regulatory success in the Middle East and opening access to a rapidly expanding regional market.

Fisher & Paykel Healthcare has reported a record full-year revenue of NZ$2.02 billion for FY2025, alongside a 43% increase in underlying net profit after tax. The company also raised its dividend, reflecting strong operational performance and strategic investments.

Atomo Diagnostics has landed a significant $450,000 order to supply HIV self-tests for a federally funded Australian program aimed at increasing at-home testing among high-risk groups.

OncoSil Medical has secured $8.7 million through a placement and share purchase plan to fund commercialization of its pancreatic cancer treatment device, aiming for positive cash flow by mid-2026. Near-completion clinical trials could soon unlock broader market access.

TruScreen Group Ltd reports a dip in FY25 sales but forecasts a robust rebound in FY26 driven by resumed programs and expansion in key emerging markets. Strategic partnerships and AI-enabled technology underpin its growth ambitions.

TruScreen Group Limited reported a 19% revenue decline in FY2025 due to delayed rollouts in key emerging markets but anticipates a strong rebound with FY2026 sales forecast to exceed NZ$2.8 million.

EBR Systems has announced a fully underwritten A$55.9 million capital raise alongside a Security Purchase Plan to fund the commercial rollout of its FDA-approved WiSE CRT System, targeting a US$3.6 billion market opportunity in cardiac resynchronization therapy.

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.