Latest Fda Submission News

Tissue Repair advances its US Phase III chronic wound trial with 100 patients randomised and targets October FDA 510(k) submission. The company reports a robust cash position bolstered by R&D refunds and has cut manufacturing scale-up costs.

Cleo Diagnostics has entered the critical Analytical Validation phase for its ovarian cancer blood test, progressing toward an FDA 510(k) submission targeted for the first half of 2027. The company also secured a U.S. reimbursement pathway to support early market entry post-clearance, backed by a cash balance of A$6.2 million.

ReNerve Limited delivered its strongest sales quarter ever with $211,000 in revenue, boosted by new distribution deals in Asia-Pacific and a $5 million funding facility to underpin growth.

Artrya is advancing its commercial footprint in the US with two health systems now generating revenue and FDA clearance for its Salix Coronary Flow module expected in H2 2026.

LTR Pharma’s SPONTAN shows rapid absorption in Phase II interim data while securing key US commercial deals for ROXUS, setting the stage for a US market entry later this year.

Optiscan Imaging has fast-tracked Stage 2 of its pioneering head and neck cancer imaging study, moving into live intraoperative imaging ahead of schedule. This advancement supports FDA regulatory efforts and enhances the company’s AI imaging development.

Imricor Medical Systems has submitted its final 510(k) devices to the FDA, marking a major step towards commercialising its MRI-guided cardiac catheterisation platform in the US.

Vectus Biosystems has appointed Cardinal Health Regulatory Services as its US regulatory agent to manage FDA submissions for its lead fibrosis drug VB0004, marking a pivotal step towards clinical development in the US.

Cleo Diagnostics (ASX:COV) has entered the analytical validation phase for its ovarian cancer test, progressing toward an FDA 510(k) submission expected in early 2027.

Optiscan Imaging has begun commercial sales of its InSpecta™ microscopic imaging device in the US veterinary sector following FDA clearance, marking its first clinical device launch and a strategic expansion into a $15.87 billion market.

Echo IQ has raised approximately A$110 million through a heavily supported institutional placement to fund its US commercial rollout and speed up development of its AI-driven cardiovascular diagnostics.

Island Pharmaceuticals has kicked off GMP manufacturing of its antiviral Galidesivir to support late-stage Marburg virus studies under the FDA Animal Rule, marking a key step towards regulatory submission and biodefence readiness.