Latest Fda Clearance News

4DMedical reports a robust 56% revenue increase in FY2025, driven by SaaS expansion and strategic partnerships, while advancing FDA clearance for its innovative CT – VQ™ lung imaging software.

4DMedical Limited reported a 56% jump in FY2025 operating revenue driven by SaaS growth, while narrowing its net loss to $30.1 million. The company also secured $13.9 million in capital and a $10 million funding facility to accelerate product commercialisation.

PainChek Limited reported a 24% revenue increase to $4.8 million for FY25, narrowing its net loss by 7%, while progressing toward FDA clearance for its Adult PainChek App in the US and launching its Infant App in Australia.

dorsaVi appoints Mathew Regan as Group CEO to spearhead commercialisation of next-gen RRAM-enabled AI and robotics technologies, aiming for global expansion.

SomnoMed delivered a strong FY25 performance with revenue climbing 22% to $111.5 million and EBITDA turning positive at $9.2 million, boosted by operational improvements and FDA clearance of its Rest Assure device. The company projects further growth in FY26 with expanded manufacturing and ongoing innovation.

SomnoMed has delivered a standout FY25 with revenue and EBITDA exceeding market expectations, driven by strong regional growth and operational improvements. The company is now expanding capacity and advancing its innovative Rest Assure device.

SomnoMed Limited reported a record FY25 with $111.5 million revenue and a return to positive EBITDA, marking a milestone of over one million patients treated globally. The company secured FDA clearance for its Rest Assure® compliance tracking device and provided optimistic guidance for FY26.

Optiscan Imaging Ltd has launched a fully underwritten $17.75 million entitlement offer to fund clinical trials and regulatory clearances for its medical devices, marking a pivotal step in its transition to a commercial medical device manufacturer.

Neurizon Therapeutics reported a $16.6 million loss for FY2025 amid significant progress in its lead neurodegenerative therapy NUZ-001, including regulatory milestones and a global licensing deal. The company is poised to enter a pivotal ALS clinical trial pending FDA clearance.

Nanosonics delivered a robust FY25 with 17% revenue growth and a 72% jump in profit before tax, propelled by next-gen trophon devices and advancing CORIS commercialisation.

PolyNovo Limited reported a robust 28.9% increase in group sales to A$118.6 million for FY25, alongside a 151% surge in net profit after tax to A$13.2 million, driven by strong U.S. growth and key regulatory approvals.

Genetic Signatures reported a 63% revenue increase to $15.9 million in FY25, alongside a 28% reduction in underlying losses and a strategic shift in its automated diagnostics platform development.