Latest Fda Clearance News

Artrya Limited has submitted a pivotal FDA 510(k) application for its AI-powered Salix® Coronary Plaque module, aiming for clearance in Q3 2025 and a lucrative US commercial launch.

PainChek has advanced its US regulatory approval process with a positive FDA meeting, setting the stage for a potential market debut of its pain assessment app in late 2025.

Mayne Pharma rebuffs Cosette's claim of a material adverse change in their merger scheme and secures FDA clearance on regulatory concerns, maintaining its commitment to the deal's completion.

Paradigm Biopharmaceuticals has reached key milestones in its global Phase 3 trial for knee osteoarthritis, activating its first Australian clinical site and enrolling the first patient. With multiple sites in Australia and the US preparing for recruitment, the trial is advancing steadily toward critical data readouts.

EMVision Medical Devices has activated two additional key sites in its pivotal trial for the emu™ bedside brain scanner, advancing its path toward FDA clearance. These new sites join a growing network of leading stroke centres across the US and Australia.

4DMedical has submitted its CT:VQ lung imaging technology for FDA clearance, aiming to disrupt the $1 billion US nuclear lung scan market with a non-nuclear, lower-cost alternative. Clinical studies show CT:VQ matches or exceeds existing nuclear imaging in accuracy and patient experience.

Echo IQ’s application for a key US procedural code was rejected but the company plans a swift resubmission, maintaining confidence in its US commercial rollout.

Lumos Diagnostics has secured its largest single US purchase order for its rapid respiratory test FebriDx, signaling growing adoption in American healthcare settings.

AVITA Medical reveals a bold expansion plan targeting a $3.5 billion U.S. acute wound care market by 2025, driven by a multi-product portfolio and sustained revenue growth.

Echo IQ has raised $17.3 million through a strongly supported institutional placement to fund US commercialization and FDA approval efforts for its EchoSolv AI cardiology products.

Cardiex Limited has formally lodged its CONNEQT Pulse device with Australia's Therapeutics Goods Administration, marking a critical step toward regulatory approval and market expansion.

Neurizon Therapeutics has announced the successful completion of its Open-Label Extension study for NUZ-001 in ALS, revealing significant survival benefits and strong tolerability. The company is on track to release top-line results in Q3 2025 and advance to a pivotal Phase 2/3 trial.