Latest Fda Submission News

EMVision Medical Devices is set to activate its sixth and final pivotal trial site at UCLA Health, advancing its emu™ brain scanner towards FDA submission. Meanwhile, the Continuous Innovation Study grows with the addition of Box Hill Hospital.

Imricor Medical Systems reports significant regulatory approvals and clinical trial progress, positioning itself as a disruptive force in the growing electrophysiology market. With a strengthened commercial pipeline and solid cash reserves, the company is poised for a pivotal growth phase.

Artrya Limited reported a 17.2% increase in net loss to $16.4 million for FY25, while achieving FDA clearance and launching its AI-driven Salix platform in the U.S. market. The company also secured key commercial partnerships in Australia and raised $20 million in equity funding.

Cleo Diagnostics has launched a health economic study in partnership with EntityRisk and Norstella to support the U.S. market entry of its Ovarian Cancer Pre-Surgical Test, aiming to refine reimbursement strategies and accelerate commercialisation.

Island Pharmaceuticals has raised $350,000 through an options exercise by substantial shareholder MWP Partners, reinforcing confidence in its antiviral drug development pipeline.

Optiscan Imaging Ltd has launched its first in-human breast cancer study and unveiled a new veterinary imaging device, while securing a key US collaboration to support FDA submissions.

Island Pharmaceuticals has completed its acquisition of the broad-spectrum antiviral Galidesivir ahead of schedule, setting sights on expedited FDA approval leveraging the Animal Rule.

Neurizon Therapeutics has made significant strides in developing its lead ALS drug candidate NUZ-001, unveiling a new liquid formulation and submitting a key regulatory response to the FDA. Clinical and preclinical data bolster hopes for broader neurodegenerative applications.

SomnoMed reports a robust Q4 FY25 with 25% revenue growth and a milestone of treating over 1 million patients, while gearing up for significant capacity expansion and clinical advancements.

Bubs Australia Limited reports a strong FY25 with 29% revenue growth to $102.5 million, positive EBITDA turnaround, and sustained cash flow improvements. The company also advances its US market ambitions with a key FDA submission underway.

Artrya has launched its AI-powered Salix Coronary Anatomy platform in the U.S. and submitted its Coronary Plaque module for FDA clearance, marking a key step in its commercial expansion. A new five-year contract with Tanner Health signals the start of U.S. revenues.

Echo IQ has secured a strategic collaboration with the Mayo Clinic Platform and raised $17.3 million, advancing its AI-driven cardiology tools towards FDA clearance and US commercial scale.