Latest Fda Clearance News

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.

Genetic Signatures Limited reported a 63% revenue surge to $15.9 million in FY25, driven by strong Australian sales and progress in EMEA, while navigating a $20.1 million net loss and a strategic pivot towards partnerships for automated diagnostics.

Artrya Limited has secured FDA 510(k) clearance for its Salix Coronary Plaque module, enabling near real-time detection of high-risk coronary artery plaque and opening a lucrative U.S. market opportunity with a $950 reimbursement per scan.