Latest Diagnostics News

Cochlear Limited reports steady FY25 financials alongside the launch of its innovative Nucleus Nexa cochlear implant system, setting the stage for projected double-digit profit growth in FY26.

Control Bionics has successfully raised $0.6 million through a shortfall placement, reinforcing investor confidence as it accelerates commercialisation of its neurotechnology in assistive communication and emerging sports markets.

Imricor Medical Systems made significant regulatory strides with FDA submissions for its MRI-guided cardiac ablation devices and launched NorthStar commercially in Europe, even as it reported increased cash outflows in Q3 CY25.

BlinkLab Limited has completed its U.S. pilot study for the Dx 1 smartphone-based autism diagnostic device, demonstrating strong accuracy and securing FDA alignment for its pivotal trial. The results mark a significant step toward transforming early neurodevelopmental diagnostics.

4DMedical secures a major commercial breakthrough with Stanford University adopting its FDA-cleared CT, VQ™ technology, while its partnership with AstraZeneca rapidly scales lung screening across Brazil.

TrivarX has completed recruitment of 60 patients in its US veteran-focused mental health trial, advancing validation of its novel single-lead ECG algorithm for depression screening. Positive interim results from 27 patients set the stage for full data release and commercial discussions.

IDT Australia announces a strategic realignment focusing on profitability and operational efficiency, reporting strong revenue growth from its three core verticals and securing $3.4 million in new contracts for FY26.

Imagion Biosystems has made significant strides toward filing an IND application for its MagSense® HER2 breast cancer imaging agent, supported by positive FDA feedback and a recent $3.5 million capital raise to fund upcoming clinical trials.

Nexsen Limited has initiated clinical trials for its StrepSure® GBS Rapid Sensor, a next-generation diagnostic device aimed at improving maternal health outcomes. The trial's success could pave the way for regulatory approval and early market penetration by the second half of 2026.

Genetic Signatures Ltd reports a robust start to FY2026 with a 20% quarterly sales increase, driven by new US contracts and strong growth in EMEA and Australia. The company also bolsters its leadership with a new CTO appointment.

BCAL Diagnostics has launched a $10 million convertible note facility, with $5 million already committed, to strengthen its capital position and accelerate commercialisation of its cancer detection technologies.

Radiopharm Theranostics has completed a A$35 million institutional placement and launched a A$5 million Share Purchase Plan, both at $0.03 per share, to fund drug manufacturing and clinical trials through 2027.