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FDA Submission
CorDx submits EUA application for COVID-19/influenza rapid test
By
LabPulse.com staff writers
CorDx has submitted an Emergency Use Authorization (EUA) application for its CorDx TyFast Flu A/B & COVID-19 Multiplex Rapid Test to the U.S. Food and Drug Administration (FDA).
February 10, 2024
NowDiagnostics submits FDA de novo request for OTC syphilis test
By
LabPulse.com staff writers
NowDiagnostics has submitted a de novo authorization request to the U.S. Food and Drug Administration (FDA) for its First to Know over-the-counter (OTC) syphilis test.
January 10, 2024
FDA grants priority review to Merck’s pneumococcal vaccine
By
LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) has granted priority review to Merck’s experimental pneumococcal vaccine, with a decision to be made on approval by June 17, 2024.
December 20, 2023
Vertex Pharmaceuticals, CRISPR Therapeutics gene-editing therapy to undergo FDA advisory committee review
By
LabPulse.com staff writers
An FDA advisory committee is scheduled to meet on October 31 to discuss and make recommendations on Vertex Pharmaceuticals' and CRISPR Therapeutics’ CRISPR-Cas9 gene-editing-based therapy, exagamglogene autotemcel.
October 30, 2023
GeninCode files pre-market notification with FDA for cardiovascular risk assessment test
By
LabPulse.com staff writers
The filing is part of GeninCode’s effort to expand its U.S. commercial distribution of CIC-SCORE; the company filed its pre-submission for GeninCode with the FDA last year.
August 18, 2023
OIG: FDA recommendations for future pandemics
By
Leo O'Connor
OIG offered numerous recommendations to manage such infectious disease emergencies, saying the FDA should access and, when appropriate, revise its guidance for Emergency Use Authorization (EUA) submissions for tests.
September 21, 2022
Cue Health requests FDA de novo clearance for at-home flu test
By
LabPulse.com staff writers
Clearance would permit the test to be used at home and elsewhere at the point-of-care (POC).
September 1, 2022
FDA issues updated reagent, instrument guidance
By
LabPulse.com staff writers
The agency said that it revised the current guidance to include point-of-care in vitro diagnostic (IVD) devices in certain situations, flowcharts, updates to examples, and further clarification of terminology.
August 15, 2022
Natera files presubmission with FDA for NIPT test
By
LabPulse.com staff writers
According to the FDA, Q-Subs can serve as helpful tools in the premarket submission process.
August 10, 2022
Abionic nabs IVDR certification for sepsis test
By
LabPulse.com staff writers
The device detects pancreatic stone protein, an early marker for sepsis, allowing for its identification in about five minutes, Abionic said.
August 8, 2022
I-calQ receives 9th patent for smartphone POC testing
By
LabPulse.com staff writers
I-calQ's technology uses the smartphone as a processor. Its camera is used to read a disposable test strip cassette, and a proprietary app that analyzes, calibrates, and quantifies results in about 10 minutes. It also has the ability to upload the data immediately.
January 14, 2021
MDIC releases IVD regulatory decision-making framework
By
LabPulse.com staff writers
The framework is designed to help the IVD industry and the U.S. Food and Drug Administration (FDA) better incorporate real-world data into development and regulatory decisions for IVD products. It also outlines the designs and statistical methods needed in order to generate real-world evidence for regulatory submissions.
August 23, 2020
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