Latest Fda Clearance News

Adherium Limited is raising up to $4 million through a partially underwritten entitlement offer to expand its US digital health platform and recruit key personnel. The capital raise supports scaling patient onboarding and advancing its FDA-cleared smart inhaler technology.

4DMedical has renewed and expanded its contract with Stanford University’s 3DQ Lab to include its innovative CT – VQ™ imaging technology ahead of FDA clearance, marking a significant step in its U.S. market expansion.

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.