510(k)
Top Five Articles on 360Dx Last Week: Blood-Based Testing in Neurology; End of NHS England; More
Last week, readers were most interested in a story about how blood-based testing is making increasing inroads for neurological conditions.
Roche, Abbott, Hologic, Cepheid, Others Gain 510(k) Clearances in February
The US Food and Drug Administration last month granted clearances for a preeclampsia risk test, respiratory disease tests, and a digital pathology system, among others.
Epredia Gains FDA 510(k) for Digital Pathology Imaging System
The firm's E1000 Dx Digital Pathology Solution consists of an automated scanner, whole-slide image viewer, and image management and viewing software.
Top Five Articles on 360Dx Last Week: Pfizer Shutting Down Lucira Health Business; More
Last week, readers were most interested in a story about Pfizer shuttering the Lucira Health business that it acquired in 2023.
Visby Medical Gains FDA 510(k) Clearance, CLIA Waiver for POC Respiratory Panel
The Visby Medical Respiratory Health Test is a disposable handheld RT-PCR-based assay for the detection and differentiation of SARS-CoV-2 and flu A/B.
Feb 13, 2025
Roche Preeclampsia Assay Nabs FDA 510(k) Clearance
Feb 11, 2025
FDA Clears BioMérieux Gastrointestinal Panel
Jan 28, 2025
Abbott Nabs FDA Clearance for Cardiac Function Test
Jan 21, 2025
Jan 10, 2025
FDA Clears Revvity Free Testosterone Assay
Oct 2, 2024