Latest Fda News

TrivarX has made significant strides in preparing its Stabl-Im stable isotope imaging platform for Phase 1 clinical trials, backed by strengthened leadership and a solid cash reserve of $2.91 million.

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.

Dimerix has completed adult patient recruitment in its Phase 3 ACTION3 trial for DMX-200, with a blinded review confirming the study remains statistically powered to demonstrate treatment efficacy. The company also appointed a new CFO and is negotiating up to US$50 million in non-dilutive funding.

Optiscan Imaging has submitted its FDA dossier for InSpecta®, marking a crucial step toward US veterinary market entry, while progressing clinical studies for InVue® and InForm® ahead of further FDA submissions in 2026.

NeuroScientific Biopharmaceuticals reported positive clinical responses in its StemSmart™ Special Access Program for fistulising Crohn’s disease and has initiated manufacturing technology transfer to support Phase 2 trials planned for late 2026.

dorsaVi has launched a multi-year partnership with Taiwan’s ITRI and NTU to develop its proprietary RRAM platform at the 22-nm node, complemented by a new advisory board and neuromorphic IP acquisition, positioning the company at the forefront of ultra-edge AI hardware.

BlinkLab has completed onboarding all clinical sites for its pivotal FDA autism trial, enrolled the first participant, and launched a nationwide autism screening program in Morocco. A recent A$17.7 million capital raise will fund further trials and expansion into ADHD diagnostics.

Epiminder has ramped up enrolment in its DETECT study, contracting 18 US medical centres and maintaining a robust $83.8 million cash position to fund its Minder device commercialisation through 2028.

ImpediMed reported a $3.5 million revenue in Q3 FY26, with reimbursement coverage in the US reaching 94.3%, supporting growth in heart health and weight management markets. New CEO Erik Anderson aims to accelerate commercial momentum and drive cash flow break-even.

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.

Syntara Limited has raised A$10 million through a two-tranche placement and share purchase plan, backing its Phase 2b myelofibrosis trial and multiple clinical readouts following positive FDA feedback.