Latest Fda Submission News

Echo IQ’s application for a Category III CPT code was declined by the AMA, but the company is exploring reconsideration and new AI-specific coding frameworks to advance US reimbursement.

Echo IQ reports a remarkable 153% increase in echocardiogram processing through its EchoSolv AS platform in the US, with a Mayo Clinic validation study nearing completion ahead of a critical FDA submission. The company is also advancing European market entry and strengthening its advisory team to accelerate global growth.

EMVision Medical Devices launches a $2 million Share Purchase Plan offering shares at a 16.4% discount, bundled with free options exercisable at $3.40, aiming to bolster clinical and commercial milestones.

EMVision Medical Devices has raised $12 million through a placement backed by institutional investors, including strategic partner Keysight Technologies, and launched a Share Purchase Plan to raise up to $2 million from existing shareholders. The capital will support key clinical and regulatory milestones for its neurodiagnostic devices over the next two years.

Imricor Medical Systems has taken a significant step toward U.S. market entry by submitting its Vision-MR Diagnostic Catheter for FDA 510(k) approval, complementing its recent NorthStar system filing. These moves aim to establish a fully integrated MRI-guided cardiac ablation platform.

4DMedical reports a robust 56% revenue increase in FY2025, driven by SaaS expansion and strategic partnerships, while advancing FDA clearance for its innovative CT – VQ™ lung imaging software.

LTR Pharma’s FY25 results reveal a transformative year highlighted by SPONTAN’s rapid absorption and strategic partnerships that pave the way for US market entry.

Tetratherix Limited advances its Tetramatrix biomaterial platform with a robust IP portfolio, scalable manufacturing, and strategic partnerships aimed at commercialising across multiple clinical franchises.

EMVision Medical Devices is set to activate its sixth and final pivotal trial site at UCLA Health, advancing its emu™ brain scanner towards FDA submission. Meanwhile, the Continuous Innovation Study grows with the addition of Box Hill Hospital.

Imricor Medical Systems reports significant regulatory approvals and clinical trial progress, positioning itself as a disruptive force in the growing electrophysiology market. With a strengthened commercial pipeline and solid cash reserves, the company is poised for a pivotal growth phase.

Artrya Limited reported a 17.2% increase in net loss to $16.4 million for FY25, while achieving FDA clearance and launching its AI-driven Salix platform in the U.S. market. The company also secured key commercial partnerships in Australia and raised $20 million in equity funding.

Cleo Diagnostics has launched a health economic study in partnership with EntityRisk and Norstella to support the U.S. market entry of its Ovarian Cancer Pre-Surgical Test, aiming to refine reimbursement strategies and accelerate commercialisation.