COVID-19 Breaking News
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FDA Clears ACON's OTC, Home COVID-19 Antigen Test
Sam Brusco, Associate Editor || 11.10.23
The Flowflex test is the second home COVID-19 test to complete the traditional FDA premarket review pathway.
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Soterix Begins RECOVER-NEURO Trial for Long COVID
Sam Brusco, Associate Editor || 08.29.23
The trial will be administered through NYU Langone Health’s home-based, remotely supervised (RS) tDCS program.
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COVID-19 Test Demand Remains High Despite Overall Caseload Decline
Michael Barbella, Managing Editor || 05.09.23
Cepheid continues to be the clear market leader in SARS-CoV-2 testing.
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FDA Grants EUA to AscencioDx COVID-19 Test, Molecular Detector
Michael Barbella, Managing Editor || 04.06.23
New reusable molecular detector reduces biowaste in clinical use.
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QuidelOrtho Earns De Novo Nod for Sofia 2 SARS Antigen+ FIA
Sam Brusco, Associate Editor || 03.09.23
First rapid antigen test that detects COVID-19 to earn FDA clearance.
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FDA Authorizes First Home Combo Flu & COVID-19 Test
Sam Brusco, Associate Editor || 02.27.23
Lucira's test can distinguish between influenza A and B, as well as SARS-CoV-2 in about 30 minutes.
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Roche Rolls Out 3 Next-Gen COVID-19 Tests in Europe
Sam Brusco, Associate Editor || 10.12.22
The new test configurations use an improved capture antibody and add new digital data-sharing capabilities.
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N95 Respirators Taken off Medical Device Shortage List
Sam Brusco, Associate Editor || 08.29.22
Increased domestic manufacturing, supply chain assessment, and new options helped beat the shortage.
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MediPines' AGM100 Effectively Triages COVID-19 Patients
Michael Barbella, Managing Editor || 07.20.22
Trial data indicate the AGM100 is useful for important hospital admission and supplemental oxygen administration decisions in coronavirus subjects.
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Hologic Rolls Out 2 COVID-19/Flu A/Flu B/RSV Tests in Europe
Sam Brusco, Associate Editor || 07.12.22
Released on the automated Panther Fusion and Novodiag systems
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BD Launches Combo COVID-19, Flu A/B, RSV Test
Sam Brusco, Associate Editor || 07.05.22
Helps eliminate the need for multiple tests or doctor visits.
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FDA Authorizes Roche's COVID-19 Test that Can Detect Viral Load
Sam Brusco, Associate Editor || 06.15.22
The automated, RT-PCR assay allows in-vitro qualitative and quantitative SARS-CoV-2 RNA detection.
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CorDx Combo Flu, RSV, COVID-19 Self-Test Gains EU Nod
Sam Brusco, Associate Editor || 06.03.22
According to the company, it's the first test of its kind in the world.
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FDA Authorizes 3-Minute COVID-19 Breath Test
Sam Brusco, Associate Editor || 04.18.22
InspectIR breathalyzer spots chemical compounds in breath samples associated with COVID-19 infection.
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Cardinal Health Tapped to Distribute Cue Health Molecular COVID-19 Tests
Sam Brusco, Associate Editor || 02.18.22
Now available through the expansive Cardinal Health distribution network.
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BD, ReturnSafe Partner to Help Businesses Manage COVID-19 Testing
Sam Brusco, Associate Editor || 02.09.22
Combined solution allows convenient, economical management of an enterprise's population.
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Siemens Healthineers Rolls Out CLINITEST COVID Rapid Self-Tests in U.S.
Sam Brusco, Associate Editor || 02.03.22
Siemens was chosen on January 24 as a test supplier to support the U.S. government’s shipping efforts.
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UC Santa Barbara Team Builds Mobile App and Lab Kit to Detect COVID-19 and Flu
Sam Brusco, Associate Editor || 02.01.22
Can be adapted for other pathogens with pandemic potential.
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Mammoth Bioscience's CRISPR-Based COVID-19 Test Earns EUA
Sam Brusco, Associate Editor || 01.25.22
High-throughput test combines CRISPR-based molecular diagnostics with lab automation.
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Hologic Adds COVID-19 Test to Global Access Initiative in Resource-Limited Countries
Sam Brusco, Associate Editor || 01.06.22
Expanded access to critical diagnostic testing with the Aptima SARS-CoV-2 assay.