Latest Fda Clearance News

PolyNovo Limited reported a robust 25.2% increase in half-year revenue to A$75 million, driven by strong U.S. sales and product growth, despite a near break-even net profit impacted by a manufacturing slowdown and a fire at its R&D lab.

Cambium Bio has secured FDA clearance to begin Phase 3 dosing for its lead ophthalmology product, Elate Ocular®, alongside key global partnerships and a $2.4 million capital injection from a major shareholder.

BlinkLab has expanded its pivotal FDA 510(k) autism diagnostic trial to nine top U.S. sites, adding Drexel University ahead of the Q1 2026 study start. This move follows a successful pilot study that exceeded FDA benchmarks, positioning BlinkLab Dx 1 for regulatory clearance.

Imricor Medical Systems has taken a significant step toward US market entry by submitting its Advantage-MR EP Recorder/Stimulator system for FDA 510(k) clearance, aiming to enhance MRI-guided cardiac procedures.

4DMedical has secured a commercial contract with University of Chicago Medicine to deploy its CT, VQ™ lung imaging technology, marking the fifth major US academic medical centre to adopt the platform since FDA clearance.

4DMedical has rapidly commercialised its CT – VQ™ lung imaging technology following FDA clearance, securing major partnerships and regulatory approvals that position it for significant growth in North America.

Artrya Limited has converted three US foundation partners into commercial customers, generating its first fee-per-scan revenues, while progressing FDA clearance for its Salix Coronary Flow module and expanding its clinical study network.

PainChek has achieved FDA regulatory clearance enabling its device to qualify for US Remote Therapeutic Monitoring reimbursement, positioning the company for significant growth in the expanding US healthcare market. The company also reports strong global licence growth and a solid pipeline across multiple regions.

PainChek has secured FDA De Novo clearance, enabling entry into the vast US healthcare market with a $3 billion Remote Therapeutic Monitoring opportunity. The company reports $5.6 million contracted ARR and a strong global footprint in aged care.

Neurizon Therapeutics has cleared a major regulatory hurdle with the FDA lifting the clinical hold on its lead drug NUZ-001 and secured a comprehensive $33 million funding package to advance its pivotal ALS trial.

Resmed Inc. posted robust Q2 FY2026 results, with revenue climbing 11% to $1.4 billion and a 16% rise in non-GAAP earnings per share, underpinned by strong global demand and operational efficiencies.

CurveBeam AI reported steady progress in Q2 FY26 with five new device purchase orders, a $4 million milestone payment pending receipt, and key regulatory submissions underway in the US and China.