Testing Blood Oxygen with Smartphones
Smartphones equipped with a deep learning algorithm are capable of detecting blood oxygen saturation levels down to 70%, according to a proof-of-principle study published in npj Digital Medicine.
Category: Testing
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Testing
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Recall for Celltrion DiaTrust COVID Rapid Tests
Celltrion USA is recalling up to 311,000 affected POC DiaTrust COVID Rapid Tests because the tests may have been distributed to unauthorized users.
Testing
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Siemens Healthineers CliniTest Antigen COVID Test Available in US
The Siemens Healthineers CliniTest Rapid COVID-19 Antigen Self-Test is now available in the United States. The test received FDA authorization in January 2022.
FDA Clears GEM Hemochron 100 Whole Blood Hemostasis Testing System
Werfen has received FDA 510(k) clearance for its GEM Hemochron 100 whole blood hemostasis system, which will be commercialized in the US in early 2022.
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FeNO Recommended for Asthma: New Clinical Practice Guideline
A new guideline from the American Thoracic Society recommends the use of fractional exhaled nitric oxide (FeNO) in patients with asthma in whom treatment is being considered.
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FDA Authorizes OTC Flowflex COVID-19 Home Test
The FDA has issued an emergency use authorization for the Acon Laboratories Flowflex COVID-19 Home Test, an over-the-counter COVID-19 antigen test.
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The Infection Control PFT Practices That Saw New Popularity During the Pandemic
The tools and best practices for handling infection control during pulmonary function testing have evolved and changed for the better during the pandemic.
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FDA Clears Siemens Healthineers’ First-of-its-kind CT Scanning Device
The US FDA has cleared the Siemens Naeotom Alpha, the world’s first photon-counting computed tomography (CT) scanner.
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Less-sensitive COVID-19 Tests May Still Achieve Optimal Results if Enough People Tested
A computational analysis of COVID-19 tests suggests that, in order to minimize the number of infections in a population, the amount of testing matters more than the sensitivity of the tests that are used.
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Frequent Antigen Testing Detects COVID-19 at Lower Cost
Antigen tests and PCR tests were equally effective in detecting SARS-CoV-2 infection when tests were given on a regular cadence every three days.
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Additional Authorization for Opti Medical SARS-CoV-2 Test
The Opti SARS-CoV-2 RT-PCR Test has received FDA Emergency Use Authorization and CE-IVD for sample handling using the OPTI Rapid Lysis Buffer.
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Exalt Single-use Bronchoscope Gets CE Mark in Europe
Boston Scientific Corp has completed CE Mark for the Exalt Model B Single-use Bronchoscope, a single-use device designed for bedside procedures in the ICU, operating room, and bronchoscopy suite.
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FDA Authorizes Symbiotica COVID-19 Self-Collected Antibody Test
The US FDA has issued an EUA for the Symbiotica COVID-19 Self-Collected Antibody Test System, the first antibody test authorized for use with home collected dried blood spot samples.
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First SARS-CoV-2 Test Granted Marketing Authorization
The FDA granted marketing authorization to the BioFire Respiratory Panel 2.1, the first SARS-CoV-2 diagnostic test permitted to be marketed beyond the COVID-19 public health emergency.
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New COVID Test Pooling Strategy Offers Early Outbreak Detection
Researchers have proposed a new quantitative strategy for pooling COVID-19 tests in order to monitor spread and detect outbreaks early within closed communities, such as nursing homes or universities.
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