Latest Diagnostics News

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.

4DMedical reports a robust 56% revenue increase in FY2025, driven by SaaS expansion and strategic partnerships, while advancing FDA clearance for its innovative CT – VQ™ lung imaging software.

BCAL Diagnostics has launched its first commercial breast cancer diagnostic test, BREASTESTplus™, in Australia, marking a key milestone despite a $7.24 million loss for FY2025. The company is also advancing its US operations with a new subsidiary and clinical trials underway.

DorsaVi Limited reported a 13.9% revenue decline and a 21.7% rise in net loss for FY25, while securing over $3 million in capital to fuel new technology ventures.