FDA Clearance

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
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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
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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
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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
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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
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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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BioMĂ©rieux'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 BioMĂ©rieux's syndromic tropical fever panel, developed in conjunction with U.S. government agencies.
December 9, 2024
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Caris Life Sciences gets FDA approval for CDx
By LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) has approved Caris Life Sciences' MI Cancer Seek for use as a companion diagnostic (CDx) to identify cancer patients who may benefit from targeted treatments.
November 6, 2024
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Qiagen receives FDA clearance for respiratory mini-panel
By LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) has cleared Qiagen's respiratory mini-panel, which is designed to aid in the diagnosis of five respiratory pathogens, for clinical use.
October 29, 2024
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FDA greenlights first non-EUA at-home flu and COVID-19 test
By LabPulse.com staff writers
Healgen Scientific's test targets proteins from both SARS-CoV-2 and flu A and B, plus updated FDA test listings.
October 8, 2024
Influenza B virus particles, colorized blue, via National Institute of Allergy and Infectious Diseases (NIAID).
NowDiagnostics at-home syphilis test gets boost from Labcorp agreement
By LabPulse.com staff writers
STI National Strategic Plan aims to reverse recent rise of STIs.
October 10, 2024
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FDA clears marketing T2 Biosystems Candida test for pediatrics
By LabPulse.com staff writers
T2Candida Panel may get a boost.
September 16, 2024
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