Latest Medical Devices News

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.

Control Bionics capped a record FY25 with 15% revenue growth, driven by US market gains and expanding NeuroNode and NeuroStrip technologies. The company also achieved a US profitability milestone and is close to finalizing key distribution partnerships.

Osteopore Limited has posted a record AUD 835K revenue in Q2 CY25, driven by strong APAC sales and new European market access following EU MDR clearance. The company also advances clinical trials and refreshes key distribution channels.

Uscom Limited reported a significant revenue decline in Q4 2025 amid global market instability but is focusing on cost management and strategic partnerships to position for recovery.

HITIQ Ltd has launched its PROTEQT smart mouthguard for grassroots sports, secured a five-year exclusive global partnership with Shock Doctor, and raised $1.9 million to fund manufacturing and market growth.

EMVision Medical Devices reports strong progress in its pivotal trial for the emu™ bedside brain scanner and successful aeromedical testing of its First Responder device, backed by a $5 million government grant and $10.5 million in cash reserves.