EUA
According to FDA documents, the test is intended to help stop the spread of COVID-19 among Amazon employees.
The system delivers its results to a companion app in about 20 minutes, according to the agency.
Dascena's COViage system uses demographic and vital-sign data pulled from a COVID-19 patients' EHR to calculate their risk of hemodynamic instability or respiratory failure.
The FDA now allows LabCorp's platform to test patients with no COVID-19 symptoms, or to run samples from up to five patients at a time.
Eko's ECG low ejection fraction tool will now be able to help clinicians spot cardiac complications associated with the novel coronavirus.
Users will now be able to collect a sample at home and send it to the lab in a sealed package.
The continuous remote monitor can help prevent complications driven by experimental COVID-19 treatments such as hydroxychloroquine or chloroquine, according to the agency.