Latest Fda Clearance News

Cardiex Limited has formally lodged its CONNEQT Pulse device with Australia's Therapeutics Goods Administration, marking a critical step toward regulatory approval and market expansion.

Neurizon Therapeutics has announced the successful completion of its Open-Label Extension study for NUZ-001 in ALS, revealing significant survival benefits and strong tolerability. The company is on track to release top-line results in Q3 2025 and advance to a pivotal Phase 2/3 trial.

Genetic Signatures Ltd reported a robust 71% jump in quarterly sales to $2.9 million, fueled by strong respiratory testing demand in Australia and key US commercial contracts. The company is advancing its automation and instrument customisation strategy to streamline molecular diagnostics offerings.

Hydrix Limited reports improved operating performance in Q3 FY25, buoyed by FDA clearance of its Gyder Surgical Hip Navigation system and a reduced cash operating loss, while managing tight liquidity with shareholder support.

dorsaVi’s Q3 FY25 report reveals growing adoption of its AI-powered video movement analysis in the US, a new elite athlete research partnership, and the launch of a pioneering 3D ACL injury prevention test.

PainChek Limited reports strong progress toward FDA De Novo clearance for US market entry, launches its Infant App in Australia, and achieves robust global licence growth with a 30% year-on-year revenue increase.

EMVision Medical Devices has commenced the pivotal clinical trial for its emu™ bedside brain scanner aimed at FDA clearance, while advancing its First Responder device through successful aeromedical testing and ethics approvals. The company maintains strong cash reserves of $12.58 million to support ongoing innovation and clinical activities.

4DMedical Limited reports a 103% surge in year-to-date revenue, secures major contracts with leading healthcare providers, and advances its CT:VQ™ technology towards FDA clearance.

ReNerve Limited reported a 39% sales increase in Q3 FY25 alongside compelling clinical validation of its NervAlign® Nerve Cuff and strategic international partnerships, positioning the company for broader market penetration.

Echo IQ Limited marked a pivotal quarter with FDA clearance for EchoSolv AS, strategic US partnerships, and a clear path toward reimbursement and broader commercialisation.

Artrya Limited has launched a A$15 million capital raising to fund the development and commercial rollout of its Salix AI-powered coronary artery disease diagnostic platform, targeting the lucrative US healthcare market.

Artrya Limited has secured A$15 million through a two-tranche placement aimed at accelerating regulatory approvals and commercial rollout of its Salix® coronary artery disease diagnostic software in the US.