Policy and Regulation

BioMérieux's Biofire tropical fever panel gets special 510(k) clearance

By LabPulse.com staff writers

The U.S. Food and Drug Administration (FDA) has granted special 510(k) clearance to BioMérieux's syndromic tropical fever panel, developed in conjunction with U.S. government agencies.

December 9, 2024

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

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

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

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

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

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

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

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

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

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

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

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