Latest Fda Review News

4DMedical has submitted its CT:VQ™ software to the FDA, aiming to revolutionize lung ventilation and perfusion imaging by replacing traditional nuclear scans with a non-contrast CT-based solution.

EBR Systems has won FDA approval for its pioneering leadless WiSE CRT System, setting the stage for a phased US commercial rollout. The company also secured key Medicare reimbursement pathways and expanded manufacturing capacity, though financial sustainability remains a concern.

Neuren Pharmaceuticals has received official FDA minutes confirming the primary endpoints for its pivotal Phase 3 trial of NNZ-2591 targeting Phelan-McDermid syndrome, reinforcing the positive signals from earlier studies.

Imagion Biosystems has progressed its MagSense HER2 breast cancer imaging agent towards a pivotal Investigational New Drug application with the FDA, backed by a solid funding runway exceeding 13 quarters.

PainChek Ltd reports robust growth with 100,000 contracted licences globally and positive FDA clearance progress, alongside a promising launch of its Infant App targeting a vast new market.

Argenica Therapeutics has dosed 80% of patients in its Phase 2 stroke trial and gained FDA orphan drug designations for its second candidate, ARG-006. The company reports a cash-positive quarter with $15 million in reserves.

Artrya Limited reports solid progress on its FDA 510(k) application and secures a A$5 million capital raise, positioning itself for imminent commercial rollout in the US healthcare sector.

Imricor Medical Systems reports strong Q4 CY24 progress with successful FDA review, CE Mark submissions, and an 840% jump in consumables revenue, positioning the company for expanded global market penetration.

EBR Systems has announced a rescheduling of the FDA Pre-Approval Inspection for its wireless cardiac pacing device to January 14, 2025, while maintaining its regulatory approval timeline for Q1 2025 and a commercial launch later in the year.