Respiratory Sore Throat Diagnostic Cleared by FDA
The BioFire SpotFire Respiratory/Sore Throat (R/ST) Panel received FDA 510(k) clearance and CLIA) waiver approval, according to bioMérieux.
The BioFire SpotFire Respiratory/Sore Throat (R/ST) Panel received FDA 510(k) clearance and CLIA) waiver approval, according to bioMérieux.
The device, which first launched in Europe, operates on the principle of acoustic sensing, whereby the body’s physiological functions generate sounds that can be sensed, processed, and recorded with a non-invasive wearable sensor.
Authorized to be used in professional point-of-care settings, the nucleic acid amplification test can detect mpox virus and deliver results in 25 minutes.
With age-appropriate instructions, school-aged children can successfully use a nasal swab to obtain their own COVID-19 test specimen, according to research published in JAMA.
Read MoreNIH researchers have found that a novel blood test can be used to easily evaluate disease severity in patients with pulmonary arterial hypertension (PAH) and predict survivability.
Read MoreEven though demand for COVID-19 tests greatly overwhelmed supply earlier in the pandemic, rapid home tests are more available today.
Read MoreThe US FDA authorized use of the Labcorp Seasonal Respiratory Virus RT-PCR DTC Test — the first COVID-Flu-RSV test without the need for a prescription.
Read MoreThe US FDA is warning consumers and healthcare providers to not use the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) because these tests are not authorized, cleared, or approved by the FDA.
Read MoreMesa Biotech is recalling the Accula SARS-CoV-2 Test because certain lots of the test have an increased risk of giving false positive results due to contamination at the manufacturing facility, according to an FDA alert.
Read MoreWhile rapid antigen COVID tests remain a useful tool for the detection of COVID-19 infections, continuous assessment and updating is likely needed in the context of variants of concern.
Read MoreUVA Health researchers say they have developed a better way to predict the risk of COPD for people of non-European ancestry.
Read MoreCelltrion USA is recalling up to 311,000 affected POC DiaTrust COVID Rapid Tests because the tests may have been distributed to unauthorized users.
Read MoreResearchers at the University of Florida and National Yang Ming Chiao Tung University in Taiwan have developed a 30-second COVID test that can detect coronavirus infection in as sensitively and accurately as the gold standard PCR test.
Read MoreThe ATS and ERS have updated their pulmonary function tests technical standard series to address the uncertainty around the interpretation of tests.
Read MoreThe MEDQOR Podcast Network is joined by RT Paul Nuccio to discuss lung imaging technology, specifically the use of lung ultrasound for identifying and managing lung diseases.
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