Latest Fda Clearance News

4DMedical secures a major commercial breakthrough with Stanford University adopting its FDA-cleared CT, VQ™ technology, while its partnership with AstraZeneca rapidly scales lung screening across Brazil.

Orthocell has boosted its investment in Marine Biomedical to secure exclusive global distribution rights for PearlBone™, an innovative bone substitute nearing FDA approval, enhancing its regenerative medicine portfolio.

Orthocell has raised $30 million through an institutional placement to accelerate the US commercialisation of its flagship nerve repair product Remplir and expand its regenerative medicine portfolio.

PainChek Limited has confirmed FDA De Novo classification for its PainChek Adult App, promptly disclosing the material regulatory milestone to the ASX and signalling a significant step towards US market entry.

Compumedics has secured a $2.15 million placement to fast-track commercialisation of its Somfit D device following early FDA approval, positioning the company for significant growth in the US home sleep testing market.

PainChek Limited has secured its first US customer, Jewish Home Family, just days after receiving FDA De Novo clearance for its AI-powered pain assessment app, marking a significant step into the $100 million US aged care market.

Artrya Limited has successfully navigated a key FDA Q-Submission meeting, receiving clear guidance on the regulatory pathway for its Salix Coronary Flow module, with a 510(k) submission planned by year-end.

PainChek Limited has achieved a landmark FDA De Novo classification for its PainChek Adult App, positioning it as the first regulated medical device for pain assessment in the US aged care sector and opening a $100 million annual market opportunity.

The U.S. FDA has lifted the clinical hold on Neurizon Therapeutics’ lead drug candidate NUZ-001, enabling its entry into a major ALS platform trial set for Q4 2025. This regulatory milestone accelerates the company’s clinical development and opens doors for broader neurodegenerative applications.

4DMedical has secured $22.6 million through the exercise of deep in-the-money options, significantly strengthening its cash position to support the commercial rollout of its CT – VQ™ respiratory imaging technology.

CurveBeam AI Limited has secured A$6.5 million in new capital to fuel global growth of its HiRise™ weight-bearing CT scanner, deepen its partnership with orthopaedic giant Stryker, and advance a potential strategic deal in China.

CurveBeam AI has secured A$6.5 million through an institutional placement and completed a €10 million vendor financing facility to accelerate sales of its HiRise™ CT scanner. The company is also progressing a strategic partnership in China and advancing surgical robot validation.