FDA EUA

CDS algorithm that predicts COVID-19 complications receives Emergency Use Authorization from FDA
By Dave Muoio | 04:05 pm | October 06, 2020
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.
After regulatory kerfuffle, EverlyWell finally rolls out home COVID-19 sample collection
By Dave Muoio | 12:40 pm | May 19, 2020
The consumer-facing digital platform for health testing was forced to pump the brakes on a similar offering roughly two months ago.
Eko lands EUA for device that helps detect coronavirus patients with cardiac complications
By Laura Lovett | 04:53 pm | May 14, 2020
Eko's ECG low ejection fraction tool will now be able to help clinicians spot cardiac complications associated with the novel coronavirus. 
First COVID-19 diagnostic test authorized for home sample collection
By Dave Muoio | 02:07 pm | April 21, 2020
Using a designated kit ordered by a doctor, patients will be able to self-swab and mail their samples to LabCorp testing facilities. The self-collection kits will be available in "most states" in the coming weeks.
Los Angeles company falsely announces FDA authorization for two-minute COVID-19 diagnostic test
By Dave Muoio | 04:13 pm | April 02, 2020
Bodysphere's announcement was spread across a number of mainstream news and social media channels before the company released a statement that explained its misunderstanding.