Latest Medical Devices News

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.

Anteris Technologies Global Corp. reported a $22.2 million loss in Q3 2025 while progressing its DurAVR Transcatheter Heart Valve pivotal trial following key regulatory approvals. The company bolstered its cash position with a $25.2 million private placement post-quarter.

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.

Compumedics has landed a $4.9 million magnetoencephalography (MEG) system order from Beijing Normal University, pushing total MEG sales in China to $25 million and reinforcing its leadership in the Asian neuro-imaging market.

AVITA Medical reported a 13% revenue decline in Q3 2025 but improved cash efficiency and secured Medicare payment confirmations for RECELL®, positioning for growth in 2026.

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.

Monash University has secured a $799,866 Australian Research Council grant to study brain injury thresholds using HITIQ’s PROTEQT™ instrumented mouthguards, with a $200,000 pre-order confirming commercial momentum.

Nova Eye Medical reported a 20% year-on-year revenue increase in Q1 FY26, reaffirming its FY26 sales guidance and targeting breakeven EBITDA by June 2026 amid cautious commercial expansion.

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.

Nanosonics Limited has announced a $20 million on-market share buy-back program for FY26, underscoring its robust financial health and confidence in future growth driven by new product innovations.

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.