Policy and Regulation
Devyser gets IVDR approval for fetal RHD test
December 2, 2024
Cross-contamination in lab testing triggers needless recalls
November 27, 2024
FDA sounds bacteria alarms over CGMP violations in Maine
November 21, 2024
Roche gets CE Mark for ovarian cancer CDx test
November 19, 2024
FDA fall IVD roundtable avoids LDT questions
November 12, 2024
Bio-Techne hematology devices receive IVDR certification
November 12, 2024
CMS Medicare fee schedule includes blood tests for CRC screening
November 5, 2024
Caris Life Sciences gets FDA approval for CDx
November 6, 2024
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