Latest Medical Devices News

Aroa Biosurgery reported a 14% rise in product sales to NZ$44.6 million for the half-year ended September 2025, driven by strong growth in its Myriad portfolio. The company also posted a normalised EBITDA profit and reaffirmed its FY26 revenue and profit guidance.

Osteopore Limited has partnered with DKSH Malaysia in a five-year agreement to distribute its innovative dental products, aiming to capture significant growth in Malaysia’s guided bone regeneration sector.

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.

HeraMED has achieved a significant regulatory milestone with the Therapeutic Goods Administration upgrading its HeraBEAT fetal heart rate monitor to Class IIb, making it the only remote home-use device approved in Australia. This positions the company for a potentially lucrative expansion in the Australian maternity care market.

Orthocell Limited reports growing adoption of its Remplir™ nerve repair product in nerve-sparing prostate cancer surgeries across Australia, positioning for a significant U.S. market expansion. The company is investing in research and commercial infrastructure ahead of a medium-term U.S. launch.

Cyclopharm Limited reaffirms its ambitious target of 250–300 US Technegas installations by late 2026, driven by FDA approval, CMS reimbursement, and a growing pipeline of healthcare sites. The company reports record half-year revenue growth, signaling strong momentum in the expanding lung imaging market.

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.

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.