Latest Fda Clearance News

Artrya Limited reported a 17.2% increase in net loss to $16.4 million for FY25, while achieving FDA clearance and launching its AI-driven Salix platform in the U.S. market. The company also secured key commercial partnerships in Australia and raised $20 million in equity funding.

Neurizon Therapeutics reports encouraging topline results from its Phase 1 Open-Label Extension study of NUZ-001, demonstrating long-term safety and a significant survival advantage in ALS patients. These findings pave the way for the pivotal HEALEY ALS Platform Trial planned for late 2025.

EMVision Medical Devices has been awarded a $3 million non-dilutive government grant to conduct a pioneering clinical study using its telehealth-enabled emu™ brain scanner in regional South Australia, aiming to transform stroke diagnosis and treatment.

Pro Medicus has delivered a landmark FY25 with soaring revenue and profit, driven by major contract wins and strategic cloud deployments. The company’s expanding North American footprint and AI initiatives set the stage for sustained growth.

Pro Medicus Limited reports a record-breaking year with $520 million in new contracts and a surge in cloud adoption, setting the stage for continued growth. The company also advances its AI and cardiology offerings, reinforcing its market position.

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.

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.

4DMedical has landed a $10 million strategic investment from Pro Medicus, aimed at accelerating its commercial growth and advancing its CT – VQ™ technology towards FDA clearance in the US.

4DMedical reports a 56% revenue surge in FY25 alongside a strategic $10 million investment from Pro Medicus, advancing its CT, VQ™ lung imaging technology towards FDA clearance.

Cambium Bio has cleared key regulatory hurdles for its lead dry eye disease treatment, Elate Ocular, and strengthened its balance sheet with a $2.12 million placement to support upcoming Phase 3 trials.

PainChek Limited has secured a A$7.5 million placement to fuel its international expansion, with US FDA clearance for its adult pain assessment app expected imminently. The company reports strong license growth and a 26% revenue increase year-on-year.

CurveBeam AI reported a solid 18% increase in purchase orders for FY25, alongside record cash receipts and positive operational cash flow in Q4. The company is also advancing a significant vendor financing facility to support growth in key markets.