Latest Diagnostics News

Echo IQ has strengthened its partnership with Mayo Clinic to distribute its AI-driven heart failure diagnostic tool, EchoSolv HF, pending FDA clearance. The expanded agreement offers a scalable commercial pathway across a vast US hospital network.

Orbital UAV has secured a pivotal engine order for heavy-lift drones, expanded its diagnostic support with Textron Systems, and entered a strategic MoU to participate in a NATO-aligned UAV program.

BlinkLab’s smartphone-based Dx1 autism screening technology has been selected for Morocco’s government-funded national early screening program, marking a major milestone in digital health adoption and autism care.

Cleo Diagnostics has expanded its ovarian cancer biomarker panel from five to eight markers, enhancing test reliability and gearing up for FDA submission. A manufacturing deal is imminent, setting the stage for commercial rollout.

Nexsen Limited has successfully completed a pivotal FDA Pre-Submission meeting for its StrepSure® diagnostic, significantly reducing regulatory risks and advancing its entry into the large US maternal health market.

AdAlta Limited has been granted a key Canadian patent for its anti-fibrotic drug AD-214, completing its composition of matter protection across all major commercial markets. This milestone strengthens the company’s intellectual property portfolio and underpins its commercial strategy for AD-214.

Imricor Medical Systems has filed a Form 10 registration with the U.S. SEC, marking its transition to a U.S. reporting company amid ongoing FDA clearances and clinical trials. This move signals a significant step in its early commercialisation of MRI-guided cardiac ablation technology.

Lakes Blue Energy has temporarily halted gas flow testing at its Wombat-5 well to conduct extended pressure analysis, planning a perforation program to enhance production prospects.

Clarity Pharmaceuticals has unveiled compelling Phase II trial results showing its Cu-SAR-bisPSMA PET imaging agent significantly improves detection of prostate cancer recurrence over the current standard. The data, presented at the 2026 European Association of Urology Congress and accepted by European Urology journal, mark a key milestone ahead of regulatory submissions.

Resonance Health has received a $732,851 refund from the Australian Taxation Office, reflecting its FY2025 R&D tax incentive claim net of income tax payable. This cash inflow strengthens the company’s financial position ahead of its March quarterly report.

BlinkLab has completed onboarding its tenth and final clinical site for its pivotal FDA 510(k) trial of an AI-powered autism diagnostic aid, setting the stage for patient enrolment to begin this month.

Telix Pharmaceuticals has resubmitted its New Drug Application to the FDA for TLX101-Px (Pixclara®), aiming to advance a novel PET imaging agent for glioma diagnosis. The resubmission addresses prior regulatory concerns with additional data, reinforcing hopes for expedited approval.