Latest Medical Devices News

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.

Archer Materials has partnered with Belgium’s IMEC to develop a scalable, cost-effective potassium ion biosensor using silicon semiconductor technology, aiming to accelerate commercial production by late 2025.

Audeara Limited has secured a five-year licensing agreement with Eastech (Huizhou) Co., Ltd. to bring its advanced hearing technology to China’s booming medical device market, leveraging major e-commerce platforms for distribution.

ResMed Inc. reported a robust 10% increase in revenue to $5.15 billion for fiscal 2025, driven by strong demand in sleep and breathing health devices and residential care software. The company also expanded its diagnostic capabilities with the acquisition of VirtuOx, positioning itself for further growth in home-based health solutions.

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.

AVITA Medical reported a 21% increase in Q2 commercial revenue to $18.4 million and narrowed its net loss, yet faces a reimbursement hurdle that forced a downward revision of full-year guidance. The company highlights clinical progress and strategic board appointments as it navigates payment challenges.

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.