Latest Fda Submission News

CurveBeam AI has reported a record quarter for HiRise™ device purchase orders, driven by a strategic expansion with Stryker in Australia and New Zealand. The company also advanced its FDA regulatory pathway for its BMD module, setting sights on mid-2025 submission.

Orthocell Limited has reported a third consecutive quarter of record revenue, driven by strong sales growth and strategic market expansions, including a key US FDA submission for its nerve repair product Remplir™.

Immuron has submitted its Phase 2 clinical study report for Travelan® to the FDA, revealing statistically significant immunological and microbiome benefits. The company is preparing to engage the FDA for Phase 3 trial discussions while progressing a large field study with military personnel.

4DMedical has landed a paid pilot contract with the US Department of Defense to deploy its CT:VQ™ lung imaging technology on active-duty personnel, marking a significant step before FDA submission and spotlighting a billion-dollar market opportunity.