Policy and Regulation

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FDA issues draft guidance for IVDs for emerging pathogens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The U.S. Food and Drug Administration (FDA) has released a draft guidance giving recommendations for validating in vitro diagnostic devices (IVDs) for emerging pathogens during a declared emergency.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

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

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

Prepared to revisit clinical laboratory price transparency?

By LabPulse.com staff writers

The Clinical Laboratory Price Transparency Act of 2023 was referred to the U.S. House Ways and Means Subcommittee this week.

December 20, 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

USPSTF proposes new cervical cancer screening guidelines

By Liz Carey

While some signals abroad favor HPV DNA testing, USPSTF stays focused on cervical cytology alone or in combination.

December 11, 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

BioMérieux's Biofire tropical fever panel gets special 510(k) clearance

By LabPulse.com staff writers

The U.S. Food and Drug Administration (FDA) has granted special 510(k) clearance to BioMérieux's syndromic tropical fever panel, developed in conjunction with U.S. government agencies.

December 9, 2024

$16.5B CDMO deal unhindered by role in broader pharma supply chain

By Liz Carey

Novo Holdings greenlighted by European Commission to take control of U.S.-based CDMO.

December 11, 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

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