Latest Medical Devices News

SomnoMed Limited reported a robust FY25 with revenue surpassing guidance and a landmark FDA clearance for its Rest Assure® oral device, setting the stage for sustained growth in oral appliance therapy.

ReNerve Ltd reports a strong 53% year-on-year revenue increase, expanding its US distribution network and advancing clinical studies for its nerve repair products. The company is poised for significant global market growth with new partnerships and upcoming product launches.

Anteris Technologies Global Corp. has filed a Form S-1 registration statement with the SEC to enable resale of shares issued in a recent private placement, marking a key step in advancing its DurAVR transcatheter heart valve system and pivotal clinical trials.

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.

Fisher & Paykel Healthcare reported a robust 14% revenue increase and a 39% jump in net profit for the first half of fiscal 2026, driven by strong clinical adoption and product innovation.

Aroa Biosurgery has reported a strong first half for FY26, with 14% revenue growth driven by its Myriad product line and a return to positive EBITDA. The company also secured relief from ASX quarterly reporting requirements, signaling improved financial stability.

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.