Latest Medical Device Innovation News

Anteris Technologies has secured regulatory green lights for its pivotal PARADIGM trial and raised $25.2 million in capital, advancing its innovative DurAVR® transcatheter heart valve towards commercialisation.

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.

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.

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.

ReNerve Limited has achieved its first commercial sales of the EmpliQ™ amniotic tissue products, marking a significant step in its transition from R&D to commercialisation. The EmpliQ™ range complements its existing nerve repair solutions and targets a growing global wound care market.

Micro-X Ltd has secured a $4.4 million Australian Government grant to develop and trial a portable Head CT scanner designed for standard ambulances, aiming to transform emergency stroke care with faster diagnosis and treatment.

EBR Systems has secured final CMS approval for Transitional Pass-Through reimbursement for its WiSE CRT System, effective October 1, 2025, enhancing hospital adoption prospects in the U.S.

Compumedics has reported record-breaking sales orders and revenues for FY25, driven by strong US market growth and SaaS adoption, setting the stage for an ambitious FY26 expansion.

ReNerve Limited has achieved a key milestone with its first sale and clinical use of a deep dermal tissue product in the US, broadening its surgical applications beyond nerve repair. This move complements its existing nerve repair portfolio and sets the stage for further product launches later this year.

EBR Systems has secured FDA approval for its pioneering leadless WiSE CRT System and obtained key Medicare reimbursement endorsements, setting the stage for its commercial rollout. The company also completed a significant capital raise to support its market expansion.

EBR Systems has won final CMS approval for New Technology Add-On Payment reimbursement, paving the way for Medicare coverage of its innovative WiSE cardiac pacing system starting October 2025.

PainChek has completed its final FDA submission for the PainChek Adult App, targeting the US long-term care market with a potential $100 million annual opportunity. A regulatory decision is expected within 75 days, setting the stage for rapid commercialisation.