Latest Fda Clearance News

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.

PainChek appoints seasoned US medtech executive Karen Holzberger as CEO to spearhead growth following FDA clearance and major US contracts.

Neurotech International has locked in a $3.15 million secured loan against its anticipated R&D tax incentives to fund pivotal Phase III autism trials and ongoing operations.

EMVision Medical Devices has hit key enrolment milestones in its pivotal brain scanner trial, expanded clinical endpoints, and maintained a strong cash position with $17.1 million on hand.

Neurotech International has secured FDA clearance for its Investigational New Drug application for NTI164, enabling clinical development in the US and advancing its global registration and commercialisation plans.

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.

PainChek announces the immediate departure of CEO Philip Daffas, with COO Andy Hoggan stepping in as interim leader amid a strategic pivot to boost US market growth following FDA clearance.

BCAL Diagnostics has acquired a 10.2% stake in Genetic Signatures for $1.39 million, aiming to merge early cancer detection with infectious disease diagnostics and expand its international footprint.

Imricor Medical Systems expands its US market reach with FDA 510(k) clearances for pediatric use of its NorthStar system and Vision-MR Diagnostic Catheter, enabling radiation-free cardiac catheterisations for children.

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.

4DMedical has cleared a major regulatory hurdle with the Therapeutic Goods Administration approving its CT:VQ™ lung imaging software, paving the way for commercial use across Australia and strengthening its global footprint.