Latest Diagnostics News

Imagion Biosystems has reached key milestones in its MagSense® HER2 breast cancer imaging program, including starting manufacturing for its Phase 2 trial and launching an AI imaging protocol collaboration with Wayne State University.

Rewardle Holdings reported a modest revenue increase for FY25 but saw its loss more than double, driven by investments in AI-powered MedTech associate CloudHolter and expanded platform initiatives.

4DMedical has secured multi-year agreements to deploy its advanced lung imaging technology across Brazil and Australia, supporting national lung cancer screening programs and enhancing lung health diagnostics.

Proteomics International has unveiled new clinical data confirming its PromarkerEso blood test can accurately detect early stages of esophageal adenocarcinoma, potentially transforming screening for a cancer with poor prognosis.

Compumedics has secured FDA clearance for its single-use Somfit®D device, effectively doubling its addressable U.S. home sleep testing market to an estimated US$240 million annually. This milestone positions the company to capture significant market share with a dual-platform EEG-based solution.

ABx Group’s latest ANSTO leach tests confirm over 70% extraction of critical heavy rare earths dysprosium and terbium from its Deep Leads project, reinforcing its path to producing a mixed rare earth carbonate sample by year-end.

4DMedical has won a crucial US Medicare reimbursement for its CT, VQ™ lung imaging software, paving the way for rapid adoption across American hospitals. This milestone follows FDA clearance and promises to transform lung diagnostics with safer, faster scans.

4DMedical has bolstered its financial footing with a $6 million R&D tax incentive and a $10 million strategic investment, while its XV LVAS® technology gains clinical validation for predicting serious COPD treatment complications.

Lumos Diagnostics has secured a significant follow-on contract with Aptatek Biosciences to push forward the development of an innovative in-home monitoring device for Phenylketonuria (PKU), a rare genetic disorder. This next phase aims to bring the FDA Breakthrough Device-designated PheCheck™ closer to clinical trials and commercial readiness.

Lumos Diagnostics, backed by BARDA, is set to begin a pivotal pediatric clinical study to extend the use of its rapid respiratory infection test, FebriDx, to children aged 2–12 in U.S. CLIA-waived settings, potentially unlocking a $1 billion market.

Imricor Medical Systems has taken a significant step toward U.S. market entry by submitting its Vision-MR Diagnostic Catheter for FDA 510(k) approval, complementing its recent NorthStar system filing. These moves aim to establish a fully integrated MRI-guided cardiac ablation platform.

4DMedical Limited has secured FDA clearance for CT – VQ™, the first non-contrast CT-based ventilation-perfusion imaging technology, promising to transform lung diagnostics by replacing traditional nuclear scans.