Latest Fda Clearance News

UC San Diego Health has begun clinical use of 4DMedical’s CT – VQ™, marking the fourth leading US academic medical centre to adopt this innovative lung imaging technology since FDA clearance. This milestone underscores 4DMedical’s rapid commercial traction and growing influence in respiratory diagnostics.

Arovella Therapeutics has taken a significant step forward by submitting an IND application to the U.S. FDA for its lead CAR-iNKT cell therapy, ALA-101, targeting blood cancers. This milestone paves the way for a first-in-human Phase 1 trial in both Australia and the U.S.

4DMedical secures Cleveland Clinic as the third major US academic medical centre to adopt its CT – VQ™ respiratory imaging technology, marking rapid commercial traction post-FDA clearance.

Echo IQ has formally lodged its FDA 510(k) submission for EchoSolv HF, an AI-driven heart failure diagnostic software validated by Mayo Clinic data, aiming to tap into a $60 billion US market.

4DMedical has locked in $30.2 million through an underwriting agreement ensuring full exercise of its listed options, lifting its cash reserves to $63.7 million and setting the stage for a pivotal year in commercialising its CT – VQ™ technology.

Neurizon Therapeutics has secured FDA clearance for its lead drug candidate NUZ-001 to enter the HEALEY ALS Platform Trial, marking a key regulatory milestone and setting the stage for patient enrollment in early 2026.

Artrya Limited has landed a significant three-year commercial agreement with Northeast Georgia Health System, marking its second U.S. customer for the AI-powered Salix platform. This deal accelerates Artrya’s footprint in cardiovascular diagnostics across a major U.S. health network.

Singular Health has submitted a 510(k) premarket notification to the FDA for its enhanced 3DICOM MD Cloud platform, aiming to expand imaging capabilities and introduce a scalable, cloud-native solution for medical image management.

SomnoMed Limited reported a robust FY25 with revenue surpassing guidance and a landmark FDA clearance for its Rest Assure® oral device, setting the stage for sustained growth in oral appliance therapy.

ReNerve Ltd reports a strong 53% year-on-year revenue increase, expanding its US distribution network and advancing clinical studies for its nerve repair products. The company is poised for significant global market growth with new partnerships and upcoming product launches.

PainChek Ltd has secured FDA De Novo clearance for its Adult App, marking a pivotal entry into the US long-term care market and setting the stage for global expansion including its Infant App.

Aroa Biosurgery reported a 14% rise in product sales to NZ$44.6 million for the half-year ended September 2025, driven by strong growth in its Myriad portfolio. The company also posted a normalised EBITDA profit and reaffirmed its FY26 revenue and profit guidance.