Latest Diagnostics News

Clarity Pharmaceuticals has signed a significant manufacturing supply agreement with Theragenics to produce copper-64, a key isotope for its upcoming prostate cancer diagnostic, Cu-SAR-bisPSMA. This deal strengthens Clarity’s US supply network ahead of anticipated FDA approval and commercial launch.

Integral Diagnostics has confirmed Jason Martinez will take over as Managing Director and CEO in August 2026, with Dr Ian Kadish remaining in charge until then to ensure a smooth transition.

BlinkLab has enrolled its first participant in the pivotal FDA 510(k) validation study for its autism diagnostic aid, BlinkLab Dx1, aiming for regulatory submission by the end of 2026.

Radiopharm Theranostics reports promising second interim Phase 2b results for RAD 101, showing 90% concordance with MRI in detecting brain metastases and encouraging sensitivity and specificity trends.

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.