Latest Fda Clearance News

CurveBeam AI reported a strong Q4 FY25 with record customer receipts and an 18% rise in purchase orders, while advancing key regulatory milestones and securing a major financing facility.

Radiopharm Theranostics reports significant progress in its oncology radiopharmaceutical pipeline, including FDA Fast Track designation and dose escalation approvals, supported by a solid cash runway through mid-2026.

PainChek Limited has raised A$7.5 million through a strongly supported placement to accelerate its US market entry following anticipated FDA clearance and expand its innovative AI pain assessment technology internationally.

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.

Radiopharm Theranostics has received FDA clearance to begin a Phase I clinical trial for RV-01, a novel radiopharmaceutical targeting the 4Ig isoform of B7-H3 in solid tumors, marking a significant step forward in cancer treatment innovation.

Singular Health has landed a pivotal $2 million US pilot contract with Provider Network Solutions and completed an $8 million capital raise, advancing its medical imaging platform’s regulatory and product development milestones.

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.

Tetratherix Limited has marked a pivotal quarter with a $25 million ASX listing, an exclusive licensing agreement with Bio Optix for ophthalmic devices, and progress on FDA regulatory submissions for its prostate spacer product.

PainChek has completed its final FDA submission for the PainChek Adult App, targeting the US long-term care market with a potential $100 million annual opportunity. A regulatory decision is expected within 75 days, setting the stage for rapid commercialisation.

4DMedical has renewed its three-year contract with the University of Michigan Medical Center, reinforcing its foothold in US respiratory imaging. Alongside, a pivotal clinical study validates its technology’s ability to detect early lung disease, while a substantial Australian grant boosts its AI research.

Cambium Bio has secured FDA clearance to begin Phase 3 dosing of Elate Ocular, a promising treatment for moderate to severe dry eye disease, pending additional financing.

Orthocell has achieved a significant milestone by recording its first US sales revenue for Remplir™, its flagship nerve repair product, shortly after FDA clearance and initial surgical use.