Compliance and Regulation

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

Mayo Clinic Laboratories, Lucence partner to expand access to liquid biopsy

By LabPulse.com staff writers

Mayo Clinic Laboratories and Lucence have announced a strategic collaboration to expand international access to Lucence's liquid biopsy technology.

January 13, 2025

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

FDA issues draft guidance for IVDs for emerging pathogens

By LabPulse.com staff writers

The U.S. Food and Drug Administration (FDA) has released a draft guidance giving recommendations for validating in vitro diagnostic devices (IVDs) for emerging pathogens during a declared emergency.

January 8, 2025

Geneoscopy raises $105M for CRC, IBD test drive

By LabPulse.com staff writers

Geneoscopy has raised $105 million in a Series C funding round led by Bio-Rad Laboratories.

January 8, 2025

Galapagos to split into separate companies, lay off staff

By LabPulse.com staff writers

Pharmaceutical firm Galapagos will split into two separate companies in a restructuring that will lay off 300 employees and make changes to a major licensing agreement with Gilead.

January 8, 2025

Sysmex America, DiaCarta highlight FIT CRC screening tests

By LabPulse.com staff writers

Developments that may signal increased fecal immunochemical testing in colorectal cancer screening worldwide in 2025.

January 6, 2025

Labcorp, UHS settle False Claims Act testing allegations

By LabPulse.com staff writers

Labcorp and University Health System (UHS) have collectively agreed to pay nearly $389,000 to settle allegations that they violated the False Claims Act by delaying the submission of physician orders for lab tests to improperly bill Medicare.

January 6, 2025

U.S. and Europe grapple with medical device, IVD regulation decisions

By Liz Carey

Clinical and research laboratory community and medical device manufacturers await decisions in first quarter 2025.

January 2, 2025

Versant Diagnostics reports Avero Diagnostics partnership

By LabPulse.com staff writers

Versant Diagnostics has expanded its footprint in the Pacific Northwest through partnership affiliation with Avero Diagnostics in Bellingham, WA.

January 2, 2025

BioNTech reaches agreement with NIH, Penn on COVID-19 vaccine royalties

By LabPulse.com staff writers

German company BioNTech has entered into two separate settlement agreements with the U.S. National Institutes of Health (NIH) and the University of Pennsylvania (Penn) over royalty payments for its COVID-19 vaccine.

December 27, 2024

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

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