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.

Optiscan Imaging Ltd has reached a pivotal milestone with the completion of its cloud-based telepathology software MVP, enabling secure, real-time remote collaboration for digital pathology.

OncoSil Medical has launched a $8.7 million capital raising via a Share Purchase Plan and Placement, seeking shareholder approval for options issuance and a 400:1 share consolidation.

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.

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.

Echo IQ has raised $17.3 million through a strongly supported institutional placement to fund US commercialization and FDA approval efforts for its EchoSolv AI cardiology products.

Cardiex reports strong early sales momentum for its CONNEQT Pulse device with approximately 3,000 units sold or contracted since its mid-January launch, supported by innovative app features and operational efficiencies. Despite regulatory delays in the US pharma sector and tariff challenges, the company is positioned for scalable growth and category leadership in preventative cardiovascular care.

SomnoMed Limited reported a robust 23.2% revenue increase in Q3 FY25, reaffirming its full-year guidance while actively addressing new US tariffs through potential duty-free exemptions.