Policy and Regulation: Page 2

WHO grants 1st prequalification to Cepheid TB test
By LabPulse.com staff writers
The World Health Organization (WHO) has granted prequalification to Cepheid’s molecular diagnostic tuberculosis (TB) test.
December 6, 2024
Bacteria Mycobacterium Tuberculosis Social
FDA grants breakthrough device designation to DeepUll's bloodstream infection test
By LabPulse.com staff writers
Diagnostics developer DeepUll has received breakthrough device designation from the U.S. Food and Drug Administration (FDA) for its rapid bloodstream infection test.
December 4, 2024
Sepsis Bacteria Social
Devyser gets IVDR approval for fetal RHD test
By LabPulse.com staff writers
Devyser Diagnostics has received In Vitro Diagnostic Regulation (IVDR) certification for its noninvasive fetal rhesus D (RHD) screening test.
December 2, 2024
Patient Woman Pregnant Social
Cross-contamination in lab testing triggers needless recalls
By LabPulse.com staff writers
Cases raise awareness of the damaging consequences of erroneous microbiology laboratory testing results.
November 27, 2024
Cdc Public Health Library 23150
FDA sounds bacteria alarms over CGMP violations in Maine
By Liz Carey
Tom's troubles highlight the importance of being inspection-ready.
November 21, 2024
Fda Logo V2 Social
Large language models tapped for speeding up clinical trial enrollment in U.S.
By Liz Carey
Meanwhile, the FDA envisions integrating more clinical trial activities into local healthcare facilities, roaming mobile research units, and through at-home lab testing kits.
November 19, 2024
Clinical Trial Data Network Social
Roche gets CE Mark for ovarian cancer CDx test
By LabPulse.com staff writers
Roche has received the CE Mark under the European Union's In Vitro Diagnostic Regulation for its companion diagnostic (CDx) test, which is designed to aid in identifying ovarian cancer patients eligible for targeted treatment with Abbvie's Elahere.
November 19, 2024
Ovarian Cancer2 Social
FDA fall IVD roundtable avoids LDT questions
By Liz Carey
In addition, CAP LDT webinar offers beginning guide for phase one compliance.
November 12, 2024
Diagnostic Analyzer Lab Pcr Social
Bio-Techne hematology devices receive IVDR certification
By LabPulse.com staff writers
Bio-Techne has received In Vitro Diagnostic Regulation (IVDR) certification for its R&D Systems Hematology Controls and Calibrators.
November 12, 2024
Lab Blood Woman2 Social
CMS Medicare fee schedule includes blood tests for CRC screening
By LabPulse.com staff writers
In the 2025 Medicare Physician Fee Schedule final rule, the U.S. Centers for Medicare and Medicaid Services (CMS) updated coverage for a complete colorectal cancer (CRC) screening to include Medicare-covered blood-based biomarker CRC screening tests.
November 5, 2024
Blood Test Samples Lab Social
Caris Life Sciences gets FDA approval for CDx
By LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) has approved Caris Life Sciences' MI Cancer Seek for use as a companion diagnostic (CDx) to identify cancer patients who may benefit from targeted treatments.
November 6, 2024
Fda Button Social
Qiagen receives FDA clearance for respiratory mini-panel
By LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) has cleared Qiagen's respiratory mini-panel, which is designed to aid in the diagnosis of five respiratory pathogens, for clinical use.
October 29, 2024
Fda Button Social
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