FDA
The FDA said negative test results don’t appear to be affected.
The company landed a 510(k) for its single-source digital X-ray Nanox.ARC, and said more clearances are in the pipeline.
The Oxehealth Vital Signs system is installed in a patient's hospital room, where it can spot-measure pulse, heart, respiratory and breathing rates with no physical contact.
According to FDA documents, the test is intended to help stop the spread of COVID-19 among Amazon employees.
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The system delivers its results to a companion app in about 20 minutes, according to the agency.
Industry regulatory leaders outline the best approaches for digital health companies looking to make sense of FDA's long-in-the-tooth enforcement discretion guidelines.
An article in NEJM reports that pulse oximeters missed occult hypoxemia in more Black patients than white.
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The eXciteOSA strengthens tongue muscles through electrical stimulation, and comes with a companion app for tracking and sharing progress.