Latest Fda Clearance News

Pro Medicus delivered a robust FY26 with 28% underlying revenue growth, a surge in new contract wins worth $407 million, and a 25% increase in fully franked dividends, underpinned by strong AI product development and rapid implementations.

Imricor Medical Systems has ignited its US commercial operations with rapid adoption by top pediatric hospitals, buoyed by FDA pediatric clearances and clinical trial progress.

Philips has officially declared compatibility for Imricor’s interventional MR devices with its magnetic resonance systems, enabling commercial clinical use and collaboration at a leading cardiology congress.

Dimerix CEO Dr Nina Webster detailed the company’s geographic and product diversification at the Bioshares Summit, spotlighting the commercial potential of DMX-200 and the newly acquired Phase 2 asset DMX-652 targeting acute kidney injury.

Neurotech International has secured $4.5 million through a share placement to fund its pivotal Phase III clinical trial of NTI164 for Autism Spectrum Disorder, aiming to reach topline data readout.

Neurotech International has secured FDA clearance for its NTI164 Investigational New Drug application and obtained Notices of Allowance for two US patents, advancing its Phase 3 autism spectrum disorder program.

Epiminder has leveraged its $125 million IPO to advance clinical enrolments, boost Medicare reimbursement, and develop its next-generation Minder device, positioning for a commercial launch in early 2028.

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.

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.

ImpediMed reported a 3% revenue increase to $3.6 million in Q4 FY26, bolstered by a $15.3 million capital raise and strategic leadership hires as it pushes growth in cancer survivorship, heart health, and weight management.

Echo IQ has locked in a strategic $20 million investment and US partnership with Pro Medicus, alongside a $110 million capital raise, positioning the company for accelerated commercial expansion of its AI-driven cardiovascular diagnostics in the US.

Imricor Medical Systems has officially launched its US commercial operations, securing Rady Children’s Hospital–San Diego as the first customer for its NorthStar iMR mapping system, following key FDA clearances including pediatric approvals.