FDA clearance
Top Five Articles on 360Dx Last Week: NYS LDT Database; August's FDA 510(k) Clearances; More
Last week, readers were most interested in a story about New York state's LDT database and the insight it may provide into the broader landscape.
Abbott, Beckman Coulter, Thermo Fisher Scientific, Others Gain FDA Clearances in August
The clearances granted in August include hematology equipment, COVID-19 tests, a lupus test, and reagent packs to aid management of cancer patients.
Top Five Articles on 360Dx Last Week: 510(k) Draft Guidance; EDGC's Early Cancer Testing Plans; More
Last week, readers were most interested in a story about new draft guidance issued by the FDA covering 510(k) clearances.
Top Five Articles on 360Dx Last Week: Prison for Lab Owner; Grail's Cancer Detection Deal; More
Last week, readers were most interested in a 27-year prison term handed down for a $463 million scheme to defraud Medicare.
PixCell Medical Nabs FDA 510(k) for POC Direct Capillary Sampling
The HemoScreen complete blood count analyzer previously received clearance in 2018 for use with venous and capillary blood samples.
Jun 30, 2023
Renalytix Kidney Disease Test Gets FDA Clearance
Jun 27, 2023