Latest Fda Clearance News

Cleo Diagnostics has laid out a clear U.S. reimbursement pathway for its ovarian cancer test, leveraging an existing CPT code to enable early market entry and data collection ahead of FDA clearance.

Lumos Diagnostics advances US commercial rollout of FebriDx with positive reimbursement data and expanded urgent care adoption ahead of the 2027/28 flu season.

Lumos Diagnostics has reached a key enrolment milestone in its BARDA-backed FebriDx paediatric trial, unlocking a US$670,000 payment and advancing its FDA submission pathway to expand use in children aged 2-12 years.

Neurizon Therapeutics has gained ethics approval to start a Phase 1 trial of its NUZ-001 oral liquid formulation, aiming to ease treatment for ALS patients with swallowing difficulties.

EMVision is broadening its emu™ Pivotal Trial to include acute ischaemia detection, aiming to accelerate FDA clearance and enhance the brain scanner's clinical impact. Recruitment has passed 125 patients across US and Australian sites, with full enrolment expected by early 2027.

Imricor Medical Systems has secured A$60 million through a placement to fund its US commercial rollout, regulatory approvals, and clinical programs, boosting its cash reserves to nearly A$103 million.

Mesoblast Limited posted US$30.3 million in net revenues for Ryoncil® in Q3 2026, hitting key clinical milestones and securing new technology licenses that could boost its next-generation cell therapies.

4DMedical has made significant strides in commercial adoption of its CT:VQ™ lung imaging technology, securing top US hospital contracts, regulatory approvals in Europe and the UK, and a major pharmaceutical partnership, all backed by strong capital raises and inclusion in the S&P/ASX 200.

Artrya has fully integrated its Salix platform at Tanner Health, is preparing two more US sites for launch, and is finalising FDA submission for its Coronary Flow module, backed by a strong cash position of $76.6 million.

CurveBeam AI reported stable device orders but faces regulatory delays for FDA and China clearances, while securing a A$4 million investment from WEGO Orthopaedics and advancing clinical collaborations with robotic surgery systems.

Echo IQ has taken a major step in its US expansion by deploying its AI-powered EchoSolv AS software at Mount Sinai Health System, one of America’s leading cardiovascular centres. This marks a key milestone in integrating AI into routine cardiology workflows at scale.

Imricor Medical Systems advanced FDA clearances and expanded clinical trials in Q1 CY26, positioning for commercial growth despite higher operating cash outflows.