FDA Approves Lucira COVID-19 Self-Test with Rapid Results
The FDA has authorized the Lucira COVID-19 All-In-One Test Kit -- the first coronavirus diagnostic for self-testing at home and that provides rapid results.
Category: Diagnostics
Diagnostics
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Diagnostics
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FDA Clears Vida Diagnostics Additions to Lung Imaging Solution
Vida Diagnostics Inc has received 510(k) clearance from the FDA for enhancements to its LungPrint solution.
Diagnostics
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Integrating PFT Data into the Electronic Medical Record
The right knowledge and proper planning can help every healthcare facility successfully integrate their pulmonary function test data into their electronic medical record.
FDA Approves Vitalograph’s In2itive e-Diary Spirometer
Vitalograph’s next generation In2itive e-Diary combines in-clinic spirometry, home monitoring of respiratory endpoints, and eCOA data gathering functions in a robust, handheld medical device.
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FDA Authorizes ‘Pooled’ COVID-19 Testing for up to Four Samples
The FDA authorized a Quest Diagnostics COVID-19 test for “pooled” samples, allowing four people to be tested with one assay.
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ndd Medical Launches New Inline PFT Filters
ndd Medical Technologies (ndd) has introduced new single patient-use, inline filters for its...
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FDA Authorizes Enzo Biochem’s SARS-CoV-2 Test
Enzo Biochem Inc has received FDA Emergency Use Authorization (EUA) for its Ampiprobe SARS-Cov-2...
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FDA Authorizes BD Veritor 15-min COVID-19 Antigen Test
The US FDA has authorized the BD Veritor Plus SARS-CoV-2 assay, a rapid, point-of-care, antigen test manufactured by Becton Dickinson.
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COVID-19: Contaminated Bronchoscopes a Danger to Patients, HCWs
Scientists warn that reusable bronchoscopes used for COVID-19 patients could spread microbes and be a risk to patients and healthcare workers alike.
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Products 2020: Spirometry & PFT
A closer look as some of the latest spirometers and PFT/diagnostic devices on the market from Micro Direct, Morgan Scientific, Cosmed, ndd Medical, Futuremed, and Vitalograph.
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Products 2020: Blood Gas Analysis
The latest blood gas analyzers on the market from Instrumentation Laboratory, Radiometer America, Nova Biomedical, and Siemens Healthineers.
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Products 2020: Diagnostics & Testing
A look at the latest diagnostic and testing products from Ambu, Rheonix, BioFire, Hologic, and Abbott.
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FDA Revokes Authorization for Chembio Antibody COVID-19 Test
The US FDA revoked the emergency use authorization of the DPP COVID-19 IgM/IgG System, a SARS-CoV-2 antibody test from Chembio Diagnostic System Inc, due to performance concerns with the accuracy of the test.
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FDA Authorizes First Sequencing-based Test for COVID-19
The US FDA issued an emergency use authorization for the Illumina COVIDSeq Test, the first COVID-19 diagnostic test utilizing next generation sequence technology.
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CDC Develops Test to Detect Both COVID-19 and Influenza
The CDC is seeking emergency use authorization for a new diagnostic test that can simultaneously detect the SARS-CoV-2 coronavirus and the influenza virus.
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