Breath Analysis Technology Shows Promise for Pneumonia Prediction
Study demonstrates OneBreath platform can diagnose and predict pneumonia onset in cardiac surgery patients through volatile organic compound detection.
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FDA Issues Notice to Rescind Laboratory Developed Test Rule
The agency signals intent to withdraw final rule extending regulatory authority to LDTs following federal court ruling that vacated the regulation.
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FDA Grants De Novo Authorization for AI-Powered Prostate Cancer Prognostic Software
The risk stratification tool is designed to predict long-term outcomes for patients with non-metastatic prostate cancer.
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BioPorto Highlights FDA-Cleared ProNephro AKI Test Amid Growing Focus on Kidney Injury Biomarkers
Company showcases FDA-cleared ProNephro AKI test as acute kidney injury remains key focus for laboratory medicine professionals.
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FDA-Approved MI Cancer Seek Test Enhances Tumor Profiling for Precision Oncology
New whole exome and transcriptome sequencing assay demonstrates high concordance with existing companion diagnostics while requiring minimal tissue input for biomarker detection.
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