FDA clearance

Angle Gets FDA Clearance for Breast Cancer Cell Isolation System

Abbott Nabs FDA Clearance for Multiplex Molecular STI Panel

BioMérieux Joint Infection Panel Gets FDA De Novo Authorization

23andMe Gains FDA Clearance for Direct-to-Consumer Prostate Cancer Genetic Risk Test

Thermo Fisher Scientific, Diazyme Laboratories, Rheonix, Others Obtain FDA Clearances in December

Copan Diagnostics Receives FDA 510(k) Clearance for Colibri Clinical Microbiology System

Meridian Bioscience Campylobacter Assay Receives FDA Clearance

FDA Approves Thermo Fisher Scientific Oncomine Dx Assay as CDx for Janssen Lung Cancer Drug

Immunexpress Receives FDA 510(k) Clearance for Sepsis Assay

Ortho Clinical Diagnostics, Siemens Healthineers, Roche, and Others Obtain FDA Clearances in October

FDA Clears Thermo Fisher Scientific Oncomine Assay as CDx for Bile Duct Cancer Drug

Invitae Writes off $262.5M Liability Upon Failure to Meet Regulatory Milestone

Siemens Healthineers, Roche Diagnostics, Thermo Fisher Scientific, Others Nab FDA Clearances in July

First Light Diagnostics C. Difficile Test Nabs FDA Clearance

FDA Clears Sysmex Hematology Analyzer With Blood Bank Mode

FDA Approves Amgen's Lumakras for NSCLC Alongside Companion Tests From Guardant Health, Qiagen

Immunodiagnostic Systems, Retractable Technologies, Immunalysis Receive FDA 510(k) Clearances in April

FDA Grants EUA to Enzo Biochem Sample Collection Kit for COVID-19 Testing

Thermo Fisher Scientific Gets FDA EUA for High-Throughput, Automated COVID-19 Test Kit