NIH/NHLBI Funding Home Spirometer Used for Cystic Fibrosis Patients
A startup company developing a video game-based pulmonary rehab device adapted its product into a home spirometer during the COVID-19 pandemic with the support of NIH/NHLBI funding.
Category: Diagnostics
Diagnostics
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Diagnostics
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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.
Diagnostics
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WatchPAT Effective at Diagnosing Sleep Apnea in Atrial Fibrillation Patients
Itamar Medical announced results from a new study that validated the use of WatchPAT against gold standard in-lab PSG in the diagnosis of sleep apnea in patients with atrial fibrillation.
Challenges & Successes in Managing Asthma, Pulmonary Function Services During COVID-19
For many pulmonary function laboratories, the initial shock of the pandemic was accompanied by a complete halt in the workflow. Fortunately for most departments, the workflow has returned.
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NDA Submitted for Xenon Gas Lung Imaging Diagnostic
Polarean Imaging plc has submitted a New Drug Application for its hyperpolarized 129Xenon gas used to evaluate pulmonary function and to visualize the lung using MRI.
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New COVID-19 Assay Can Monitor Vaccine Responses
Leinco Technologies has developed a proprietary, fully validated assay: the COVID-19 ImmunoRank Neutralization MICRO-ELISA test.
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NDD Medical Offering New Spirometry Training Webinars
Beginning Sept 29 at 1:00pm ET, NDD Medical will offer live training webinars that will detail how to perform spirometry on its EasyOne Air and Easy-on PC spirometers.
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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.
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Guidance for Using High-Resolution CT for Interstitial Lung Disease
The Pulmonary Fibrosis Fdn has issued a position statement that serves as a guide for conducting high-resolution computed tomography of the thorax for interstitial lung disease.
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FDA Authorizes First COVID-19 Test Where Results Can Be Read Directly From Testing Card
The BinaxNOW COVID-19 Ag Card is the first antigen test where results can be read directly from the testing card, a similar design to some pregnancy tests.
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FDA Authorized Six Additional COVID-19 Tests This Week
As of Aug 13, 2020, the FDA has now authorized 213 COVID-19 tests under emergency use authorizations.EUAs, including 174 molecular tests, 37 antibody tests, and 2 antigen tests.
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FDA Approves First Liquid Biopsy + NGS Diagnostic Test for NSCLC
The FDA has approved the first liquid biopsy companion diagnostic that also uses next-generation sequencing technology to ID EGFR gene mutations in metastatic non-small cell lung cancer.
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Olympus Launches New EBUS-TBNA Needle for Lung Cancer Staging and Diagnosis
Olympus has launched the ViziShot 2 25 G, an endobronchial ultrasound transbronchial aspiration (EBUS-TBNA) needle portfolio for lung cancer diagnosis and staging.
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FDA Authorizes GWU SARS-CoV-2 Test
The FDA issued an emergency use authorization for the GWU SARS-CoV-2 RT-PCR Test to George Washington University’s Public Health Laboratory.
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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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