Latest Medical Devices News

EMVision Medical Devices has begun a pivotal aeromedical study with the Royal Flying Doctor Service to test its portable First Responder brain scanner in remote emergency settings. The trial aims to validate device usability and workflow integration ahead of commercial rollout.

PainChek Ltd has secured FDA De Novo clearance for its Adult App, marking a pivotal entry into the US long-term care market and setting the stage for global expansion including its Infant App.

ReNerve Limited has raised $3.2 million through a two-tranche share placement to accelerate its sales and marketing efforts in the US and support upcoming product launches, including a new nerve conduit range.

ParagonCare reported solid FY25 results, progressing well on its complex merger integration and expanding its footprint in Asia through the acquisition of Somnotec Group.

ResMed Inc has updated the foreign exchange rate for its upcoming dividend payable to ASX CDI holders, impacting the Australian dollar amount investors will receive.

ReNerve Limited’s innovative NervAlign® Nerve Cuff has secured approval for use across the US Department of Defense and Veterans Affairs healthcare systems, marking a major milestone for the Australian medtech company.

Anteris Technologies has gained FDA approval to start patient recruitment in the US for its pivotal PARADIGM Trial, following initial European regulatory success. The company advances manufacturing and clinical readiness as it pushes toward key regulatory milestones.

EBR Systems has achieved a major commercial milestone with Medicare reimbursement approvals for its wireless cardiac pacing WiSE CRT System, driving a 201% revenue increase in Q3 2025. The company is advancing its Limited Market Release as it scales adoption in the US.

Control Bionics has integrated Apple’s Brain-Computer Interface protocol into its NeuroNode products, promising simpler setup and enhanced communication for users with severe impairments.

AVITA Medical reported a 13% drop in Q3 commercial revenue to $17.1 million but improved its net loss and secured CE Mark approval for RECELL GO in Europe, signaling strategic shifts ahead.

ReNerve Limited is scaling up its clinical trial for the NervAlign® Nerve Cuff following promising interim results that show significant pain reduction in nerve repair patients. The expanded study aims to solidify evidence for broader regulatory approval and market adoption.

Orthocell has appointed a second Canadian distributor for its nerve repair device Remplir™, achieving full national coverage and setting the stage for initial sales this quarter.