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Regulatory Approval: Page 2
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
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
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
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 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
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
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
Karius gets FDA breakthrough device designation for infectious disease test
By
LabPulse.com staff writers
Karius announced today that its Karius Test for the diagnosis and management of lung infections in immunocompromised patients has been granted breakthrough device designation from the FDA.
May 16, 2024
Roche, Lilly Alzheimer's blood test granted FDA breakthrough device designation
By
LabPulse.com staff writers
The Alzheimer's blood test developed through a collaboration between Roche and Lilly has been granted a breakthrough device designation by the U.S. Food and Drug Administration (FDA).
April 11, 2024
Roche's breast cancer CDx receives CE Mark
By
LabPulse.com staff writers
Roche has received the CE Mark for the first companion diagnostic (CDx) test to identify patients with HER2-low metastatic breast cancer who may be eligible for treatment with Enhertu.
April 10, 2024
Bio-Techne receives IVDR certification for chronic myeloid leukemia monitoring test
By
LabPulse.com staff writers
Bio-Techne has announced that Asuragen, part of its molecular diagnostics division, has completed class C certification under the new European Union IVDR for its QuantideX qPCR BCR-ABL IS kit for monitoring chronic myeloid leukemia.
March 22, 2024
FDA accepts 1st AI-based tool into Istand pilot program
By
LabPulse.com staff writers
A mental health assessment tool has become the first AI-powered tool to be accepted into the U.S. Food and Drug Administration's (FDA) Innovative Science and Technology Approaches for New Drugs (Istand) pilot program for advancing drug development.
January 26, 2024
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