Latest Clinical Studies News

Lumos Diagnostics has enrolled 500 patients in its FebriDx CLIA waiver clinical study, unlocking a significant milestone payment from BARDA and moving closer to FDA approval that could open a US$1 billion market.

Artrya Limited has submitted a pivotal FDA 510(k) application for its AI-powered Salix® Coronary Plaque module, aiming for clearance in Q3 2025 and a lucrative US commercial launch.

Opyl Limited has secured strategic collaborations with two leading contract research organisations, integrating its AI-driven TrialKey platform into cardiovascular, oncology, and rare disease clinical trials to enhance trial design and accelerate commercial growth.

Cleo Diagnostics unveils a pioneering blood test for early ovarian cancer detection, boasting superior accuracy to existing methods and targeting a significant U.S. market opportunity.

Lumos Diagnostics has reached 50% recruitment of bacterial positive patients in its pivotal FebriDx CLIA waiver clinical study, setting the stage for a planned FDA submission in late 2025 and unlocking a substantial US market opportunity.

TruScreen Group Limited forecasts a robust 64% increase in FY26 sales, driven by strategic market expansions and new distribution agreements. The company’s AI-enabled cervical cancer screening technology is gaining traction across emerging markets.

TruScreen Group Limited has announced a NZ$3 million capital raise to fund strategic growth initiatives across Asia and Africa, alongside repaying existing debt. The raise includes a placement and share purchase plan with free attaching options, signaling confidence in its expanding cervical cancer screening programs.

4DMedical has submitted its CT:VQ lung imaging technology for FDA clearance, aiming to disrupt the $1 billion US nuclear lung scan market with a non-nuclear, lower-cost alternative. Clinical studies show CT:VQ matches or exceeds existing nuclear imaging in accuracy and patient experience.

TruScreen Group Limited reported a 19% revenue decline in FY2025 due to delayed rollouts in key emerging markets but anticipates a strong rebound with FY2026 sales forecast to exceed NZ$2.8 million.

EBR Systems has announced a fully underwritten A$55.9 million capital raise alongside a Security Purchase Plan to fund the commercial rollout of its FDA-approved WiSE CRT System, targeting a US$3.6 billion market opportunity in cardiac resynchronization therapy.

Microba Life Sciences reveals breakthrough data showing its MetaPanel™ test detects elusive gastrointestinal pathogens in 20% of chronic cases, enabling targeted treatment and complete symptom resolution.

Rhythm Biosciences’ subsidiary Genetype has landed a pivotal 12-month contract with the University of Melbourne to provide advanced breast cancer risk assessments, marking a significant step in personalised cancer screening.