Latest Medical Devices News

Anteris Technologies reported solid clinical progress with 130 patients implanted with its DurAVR heart valve and is gearing up for its pivotal PARADIGM trial with 79 qualified sites worldwide. The company also strengthened its leadership with two new board members amid ongoing FDA engagement.

Anteris Technologies Global Corp. reported a $42.7 million net loss for the first half of 2025 amid advancing preparations for its pivotal DurAVR Transcatheter Heart Valve trial. The company’s recent IPO proceeds are fueling R&D and manufacturing scale-up as it targets regulatory approvals.

Avita Medical reported an 18% revenue increase and a 30% reduction in net loss for the first half of 2025, signaling progress as it scales commercial operations and targets profitability by 2026.

AVITA Medical has filed its Q2 2025 Form 10-Q, reaffirming its leadership in acute wound care with its FDA-approved RECELL System and expanding international footprint.

AVITA Medical’s Q2 2025 update reveals a temporary setback in RECELL demand due to Medicare reimbursement delays, offset by strong revenue growth and promising clinical data. The company anticipates recovery and renewed growth in the second half of the year.

Universal Biosensors updates investors on a shift from a secured loan to a potential entitlement offer, signaling evolving funding strategies and extended timelines.

Atomo Diagnostics has secured a US$410,000 order from Lumos Diagnostics for its Pascal test cassettes, following Lumos's exclusive six-year US distribution deal for the FebriDx test with PHASE Scientific.

Nanosonics has secured FDA clearance for its next-generation trophon3 device and trophon2 Plus software upgrade, setting the stage for significant growth in the US medical disinfection market.

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.

HeraMED Limited has resumed trading on the ASX following the release of its quarterly reports and a significant capital raising announcement, marking a pivotal moment for the medical device company.

Cardiex reported strong growth in its Pulse arterial health monitor sales during Q4 FY25, surpassing A$0.7 million for the year and advancing its transition to subscription-based digital health services.

Cardiex Limited reported a $3 million cash outflow in Q4 2025 but is banking on cost reductions and new product sales to improve its financial footing. The company also secured $6.5 million through a capital raise to bolster its runway.