Regulatory Approval

Roche whole-slide imaging system gets additional 510(k) clearance

By LabPulse.com staff writers

The Roche Digital Pathology Dx imaging system has received an additional 510(k) clearance from the U.S. Food and Drug Administration.

January 9, 2025

Health Canada grants approval for MedMira's HIV and syphilis test

By LabPulse.com staff writers

Regulatory body Health Canada has granted approval to MedMira's point-of-care test for HIV and syphilis.

December 27, 2024

Roche broadens availability of standardized clinical mass spec

By LabPulse.com staff writers

Company received CE Mark for its Cobas Mass Spec system.

December 18, 2024

Roche receives CE Mark for updated Cobas systems

By LabPulse.com staff writers

Roche has received the CE Mark for its updated Cobas 6800 and 8800 systems.

December 13, 2024

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

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

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

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

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