Latest Fda Submission News

Cleo Diagnostics reports steady progress in its U.S. and Australian clinical trials for an ovarian cancer blood test, maintaining a solid cash reserve of A$7.3 million as it prepares for FDA submission.

Control Bionics has delivered its strongest US sales quarter in years, nearing US$1 million in revenue, while broadening its market footprint with new commercial agreements and cost optimizations.

TrivarX has solidified its regulatory strategy for the pivotal MEB-001 trial with the FDA and unveiled a new algorithm that expands its mental health screening reach beyond sleep clinics.

ReNerve Limited has reported a remarkable 260% increase in quarterly sales following its successful IPO, alongside strategic distribution deals in Hong Kong and the Middle East. The company is poised for further growth with upcoming clinical data and product developments.

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.