Latest Diagnostics News

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.

Rewardle Holdings reports a sharp 497% increase in half-year losses amid strategic investments in its MedTech partner CloudHolter and fintech expansions. Despite financial headwinds, the company advances its B2B2C platform with a focus on growth and innovation.

Singular Health Group reported a $6.38 million loss for FY2025 while securing a pivotal $1.3 million commercial agreement with US-based Provider Network Solutions to deploy its 3DICOM software. The company also completed a major cloud migration of its platform, positioning itself for growth in the US healthcare market.

Echo IQ Limited reported a sharp increase in losses for FY25 despite revenue growth, while securing FDA clearance and expanding its AI-driven cardiology platform across major US networks.

Resonance Health reports robust FY25 results with 29% revenue growth and outlines ambitious FY26 guidance targeting $17 million in revenue and $2 million EBITDA. The company’s transformation into three profit-generating segments underpins its expanding footprint in the global clinical trial ecosystem.

Resonance Health Limited reported a 29% revenue increase to $11.07 million for FY25 but posted a net loss of $1.73 million, reflecting strategic investments and expansion in clinical trial services.

Alterity Therapeutics reported a reduced net loss of A$12.15 million for FY2025, buoyed by positive Phase 2 clinical trial results for its lead drug ATH434 in Multiple System Atrophy and a successful A$40 million capital raising.