Compliance and Regulation: Page 2

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
Alzheimers Phases Amyloid Social
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 Button Social
Quest completes Ohio lab assets acquisition
By LabPulse.com staff writers
Quest Diagnostics has completed its acquisition of outreach laboratory assets from University Hospitals, an academic medical center and community hospital network.
January 27, 2025
Blood Test Samples Lab Social
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
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Federal judge dismisses pathology group antitrust case
By LabPulse.com staff writers
A federal judge has dismissed an antitrust lawsuit filed last year pitting pathology groups Iowa Pathology Associates, Regional Laboratory Consultants, and Goldfinch Laboratory against one another.
January 23, 2025
Judge Gavel Court
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
Roche Brand Media Library Image 2024 Social
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
Washington Dc Capitol (2)
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
Blood Test Samples Lab (2)
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
Bacteria Blood Sepsis Social 67576a5b0e9e8
BioMĂ©rieux to acquire SpinChip
By LabPulse.com staff writers
BioMĂ©rieux has entered an agreement to acquire diagnostics firm SpinChip.
January 16, 2025
Financials Growth Revenue Business Social
Helix opens genomics to 3 health systems, plugs into Komodo Healthcare Map
By LabPulse.com staff writers
Companies learning from clinical laboratory, pharmacy, and mortality data.
January 15, 2025
Dna Sequence Shadow Social
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
Roche Brand Media Library Image 2024 Social
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