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Policy and Regulation
Vertex non-opioid analgesic gets FDA approval
By
LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) has approved Vertex’s Journavx, the first analgesic to be approved in a novel class of non-opioid pain medications indicated for moderate to severe acute pain relief.
February 4, 2025
AliveDx gets CE Mark for multiplex autoimmune test
By
LabPulse.com staff writers
AliveDx has received the CE Mark for its multiplex assay for the diagnosis of systemic autoimmune rheumatic diseases.
February 5, 2025
Modella AI gets FDA breakthrough device designation for generative AI copilot
By
LabPulse.com staff writers
Modella AI was granted a breakthrough device designation by the U.S. Food and Drug Administration (FDA) for its generative artificial intelligence (AI) copilot, PathChat DX.
February 3, 2025
AdvaMed rallies for state health policies in 2025
By
LabPulse.com staff writers
AdvaMed has released key priorities for patient advocacy organizations and professional medical societies.
January 28, 2025
Beckman Coulter gets FDA breakthrough device designation for Alzheimer's test
By
LabPulse.com staff writers
Beckman Coulter Diagnostics has been granted a U.S. Food and Drug Administration (FDA) breakthrough device designation for its Access p Tau217/β-Amyloid 1-42 assay, designed to identify amyloid pathology indicative of Alzheimer's disease.
January 28, 2025
FDA approves monthly maintenance dosing for Leqembi
By
LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) has approved Alzheimer's disease drug Leqembi for a monthly maintenance dose schedule after initial treatment.
January 29, 2025
FDA reclassifications will reduce burdens for some IVD manufacturers, labs
By
Christine Bump
What happens when an IVD manufacturer or lab seeks to market an assay after its reclassification? Regulatory attorney Christine Bump responds.
January 22, 2025
FDA 510(k), CLIA waiver may boost Roche STI tests
By
LabPulse.com staff writers
Roche has been granted 510(k) clearance with a CLIA waiver for its cobas liat sexually transmitted infection (STI) multiplex assay panels.
January 22, 2025
CAP prioritizes pathologists' needs in 2025
By
Liz Carey
In a letter to the Trump administration and 119th Congress, the College of American Pathologists (CAP) prioritized the top regulatory, payer, and workforce issues facing anatomic pathologists and their teams in 2025.
January 22, 2025
IntelliGenome accelerates CRISPR-PCR TB testing studies
By
LabPulse.com staff writers
IntelliGenome's CRISPR-Tuberculosis (TB) Blood Test has received the breakthrough device designation from the U.S. Food and Drug Administration.
January 21, 2025
FDA clears Inflammatix rapid sepsis test system
By
LabPulse.com staff writers
Sunnyvale, CA-based Inflammatix has received marketing authorization from the U.S. Food and Drug Administration (FDA) for its TriVerity rapid sepsis test system
January 21, 2025
Roche gets FDA 510(k) clearance for B-cell lymphoma assay
By
LabPulse.com staff writers
Roche has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its assay designed to aid in the diagnosis of B-cell lymphoma.
January 13, 2025
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