Latest Fda Approval Process News

Imricor Medical Systems has secured Institutional Review Board approval for the University of Virginia Health to join its VISABL-AFL clinical trial, marking a key expansion in the US. Procedures are set to begin early next year, supporting Imricor’s progress toward FDA approval and commercialisation.

Neurotech International has secured a key FDA designation for its lead drug NTI164, advancing its potential to treat Rett syndrome with regulatory and financial benefits.

Imricor Medical Systems has successfully completed a comprehensive Human Factors study for all its devices under FDA review, marking a critical milestone towards U.S. market entry. The extensive 7-month study involved 46 healthcare professionals and tested nine products, underscoring Imricor’s growing momentum in electrophysiology innovation.

Imricor Medical Systems reported a sharp 52% revenue decline and a 92% increase in net loss for H1 2025, offset by a $42.8 million equity raise boosting liquidity. The company is investing heavily in European sales and clinical trials while pursuing FDA approval.

Universal Biosensors reports a 6% sales increase in Q1 2025, driven by strong growth in wine and veterinary biosensors, while preparing to launch its innovative water testing product later this year.

Echo IQ has raised $17.3 million through a strongly supported institutional placement to fund US commercialization and FDA approval efforts for its EchoSolv AI cardiology products.

BlinkLab Limited has raised A$7.66 million through a well-supported placement to accelerate FDA regulatory trials for its autism and ADHD diagnostic platforms, leveraging its innovative smartphone-based technology.