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COVID-19
FDA issues warning for Cue Health COVID-19 tests
By
LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) issued a warning to consumers and healthcare providers not to use Cue Health's COVID-19 over-the-counter test and its COVID-19 test intended for point-of-care settings due to an increased risk of false results.
May 14, 2024
iHealth gets EUA for combination COVID-19/influenza at-home test
By
LabPulse.com staff writers
Diagnostics developer iHealth Labs has received an emergency use authorization (EUA) from the U.S. Food and Drug Administration for its 3-in-1 COVID-19/Flu A&B Rapid Test Kit for over-the-counter home use.
May 10, 2024
Study: Age-related differences in nasal cells offer COVID-19 protection
By
Matt Limb
Key differences in how the nasal cells of young and elderly people respond to the SARS-CoV-2 virus may explain why children typically experience milder symptoms of COVID-19, say researchers.
April 29, 2024
International consortium launches project to develop next generation of vaccines
By
Matt Limb
An international consortium of researchers specializing in human challenge studies is embarking on a $57 million project to develop advanced virus-blocking coronavirus vaccines.
March 15, 2024
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
COVID-19 fraud conviction overturned by federal judge
By
LabPulse.com staff writers
A federal judge has overturned a jury verdict convicting a Maryland doctor of five counts of COVID-19 testing fraud.
January 9, 2024
CEO of Decision Diagnostics pleads guilty in COVID-19 test fraud scheme
By
LabPulse.com staff writers
The CEO and sole director of Decision Diagnostics has pleaded guilty to securities fraud, wire fraud, and obstruction of an official proceeding in connection with false claims of the firm developing a rapid COVID-19 test early in the pandemic.
December 11, 2023
Texas lab owner pleads guilty in $1.7M Medicare fraud
By
LabPulse.com staff writers
A Plano, TX, lab owner has pleaded guilty to orchestrating a scheme to obtain $1.7 million from Medicare fraudulently, announced the office of the U.S. Attorney for the Northern District of Texas in a statement.
December 6, 2023
AI model shows promise detecting COVID-19 in low-resource settings
By
Will Morton
An artificial intelligence (AI) model shows promise for diagnosing COVID-19 in low-resource settings with severe shortages of medical experts, including in many African regions, according to a study published November 11 in
Scientific Reports
.
November 14, 2023
3EO Health to launch FDA-approved COVID-19 test
By
Matt Limb
Molecular diagnostics startup 3EO Health is preparing to launch a newly approved SARS-CoV-2 test with its portable molecular device, saying it will “expand access” to the technology.
October 20, 2023
Researchers develop technique for onsite detection of SARS-CoV-2
By
LabPulse.com staff writers
Researchers have developed a portable laboratory device for rapid onsite detection of SARS-CoV-2 RNA which holds promise for scenarios in which there is no or limited access to testing laboratories.
October 10, 2023
FDA issues EUAs for 2 POC COVID-19 tests
By
LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) granted emergency use authorizations (EUAs) for two separate point-of-care (POC) assays for SARS-CoV-2 developed by Tangen Biosciences and SD Biosensor.
October 4, 2023
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