Latest Fda Submission News

Cleo Diagnostics has completed alpha testing of its ovarian cancer pre-surgical triage assay kits, confirming robust performance and differentiation between benign and malignant disease. The company now moves forward to assay optimisation and manufacturing scale-up, edging closer to FDA submission and commercial launch.

4DMedical has landed a significant commercial contract with Intermountain Health to deploy its FDA-cleared Pulmonary Hypertension Analysis (PHA™) product, marking a key milestone in its U.S. expansion through a strategic Microsoft-backed partnership.

Control Bionics reports its strongest US revenue in years alongside Australia’s best quarter since 2022, propelled by new product launches and strategic investments.

Argenica Therapeutics has completed patient dosing in its Phase 2 trial of ARG-007 for acute ischaemic stroke, with topline data expected in Q3 2025. The company also plans to submit its Investigational New Drug application and Fast Track request to the FDA imminently.

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.

Lumos Diagnostics reported a 21% quarter-on-quarter revenue increase in Q3 FY25, driven by strong product sales and expanded development agreements. The company also secured Medicare coverage in key US regions and advanced its pivotal FebriDx CLIA waiver study with FDA submission expected by year-end.

Cleo Diagnostics has responded to an ASX price query following a notable rise in its share price and trading volume, underscoring its patented ovarian cancer detection technology and ongoing U.S. clinical trials.

Cardiex has kicked off deliveries of its CONNEQT Pulse arterial health monitors in the U.S., reporting strong preorder momentum and a 150% sales increase in December. The company’s strategic operational shifts and pharma partnerships set the stage for sustained growth in 2025.

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.