Regulatory Approval

FDA grants breakthrough device designation to MeMed sepsis test
By LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) has granted breakthrough device designation to MeMed for its rapid diagnostic and risk assessment test for sepsis.
December 12, 2024
Fda Sign Dc Social
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
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
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
FDA grants breakthrough device designation to Invenio's lung biopsy image analysis module
By LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) has granted breakthrough device designation to Invenio for its image analysis module that is designed to assist physicians in evaluating bronchoscopic lung biopsies.
October 30, 2024
Artificial Intelligence Lung Color Social
FDA approves Genentech's breast cancer therapy, Foundation Medicine's CDx
By LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) approved the FoundationOne Liquid test as a companion diagnostic (CDx) with Genentech's Itovebi combination therapy for certain patients with HR-positive, HER2-negative advanced or metastatic breast cancer.
October 14, 2024
Fda Sign Dc Social
Exact Sciences gets FDA approval for next-gen Cologuard Plus test
By LabPulse.com staff writers
Exact Sciences has received U.S. Food and Drug Administration (FDA) approval for its next-generation Cologuard Plus colorectal cancer (CRC) screening test.
October 7, 2024
Fda Sign Dc Social
FDA approves Illumina IVD kit as CDx
By LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) has approved Illumina's TruSight Oncology Comprehensive cancer biomarker IVD kit for use as a companion diagnostic to match patients to two targeted therapies, Bayer's Vitrakvi and Lilly's Retevmo.
August 27, 2024
Regulatory File Submit Social
Sophia Genetics platform receives CE Mark
By LabPulse.com staff writers
Software firm Sophia Genetics has received the CE Mark under the European Union's In Vitro Diagnostic Regulation for its Sophia DDM platform.
August 15, 2024
Dna Sequencing Data Analysis Social
New laboratory developed tests for colorectal cancer screening get boost from CMS
By Liz Carey
Clinical laboratory test manufacturers aim for estimated 60 million unscreened Americans as CMS meets them with a broad CRC screening test definition and proposed coverage changes in 2025.
July 31, 2024
Colorectal Cancer Social
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