Latest Diagnostics News

Singular Health has submitted a 510(k) premarket notification to the FDA for its enhanced 3DICOM MD Cloud platform, aiming to expand imaging capabilities and introduce a scalable, cloud-native solution for medical image management.

Proteomics International secures a key Medicare reimbursement rate for its PromarkerD test, a predictive diagnostic for diabetic kidney disease, marking a critical step in its US commercial rollout.

Cleo Diagnostics has secured a $1.7 million R&D tax refund, strengthening its cash reserves to $5.75 million as it advances toward a pivotal US clinical trial and FDA submission for its ovarian cancer test.

Clarity Pharmaceuticals has raised $203 million to accelerate its copper-64 and copper-67 radiopharmaceutical pipeline, targeting prostate and neuroendocrine cancers with multiple FDA Fast Track trials underway.

Enlitic has been authorised as one of two approved vendors by Philips to deliver AI-powered DICOM data migration solutions, marking a significant expansion in their partnership and positioning Enlitic for growth in the global radiology market.

Pacific Edge reports a $19.1 million net loss for the first half of FY26 amid Medicare coverage loss but positions itself for a Medicare-led recovery with strong clinical evidence and a key advisory committee meeting set for February 2026.

New data reveals that Thoroughbred racehorses free from oxidative stress are significantly more likely to win or place, spotlighting OxiDx’s patented biomarker test as a game-changer in equine performance and welfare.

Echo IQ has completed a pivotal clinical validation of its EchoSolv HF software at the Mayo Clinic, achieving outstanding accuracy ahead of its FDA submission. This milestone sets the stage for potential US market entry into a $60 billion heart failure diagnostics sector.

Lumos Diagnostics has achieved a major milestone by securing 100% Medicare reimbursement recognition for its FebriDx test across all seven US Medicare Administrative Contractors, paving the way for broader adoption in the American healthcare system.

Monash IVF Group reported a 6.7% revenue increase to $271.9 million for FY25, alongside an 8.1% decline in underlying NPAT, aligning with prior guidance. The company outlined a cautious FY26 outlook focused on innovation, doctor retention, and cost management.

Monash IVF Group reported solid FY25 revenue and EBITDA growth despite sector softness and clinical incidents, while announcing a leadership transition and dividend pause.

Sonic Healthcare has reaffirmed its FY2026 EBITDA guidance with up to 13% growth, reported solid FY2025 financial results, and announced a strategic acquisition in Germany alongside notable sustainability progress.