FDA EUA

By Dave Muoio 11:40 am May 19, 2020
Austin, Texas-based EverlyWell, a digital platform that lets consumers order lab tests online and view their results, has received an FDA Emergency Use Authorization (EUA) for a COVID-19 at-home diagnostic sample collection kit that can be used with multiple diagnostic lab tests. Announced Friday by the FDA and Monday by the startup, the EverlyWell COVID-19 Test Home Collection Kit includes nasal...
By Laura Lovett 03:53 pm May 14, 2020
Early this week cardiac-focused digital health company Eko scored a temporary Emergency Use Authorization (EUA) for its ECG low ejection fraction tool, which can be used to help clinicians spot cardiac complications associated with the novel coronavirus. Providers are able to use the tool in order to get an assessment of Left Ventricular Ejection Fraction, a measure which providers can use to...
By Dave Muoio 01:07 pm April 21, 2020
Thanks to an updated emergency use authorization (EUA) from the FDA, LabCorp's COVID-19 RT-PCR test is now the first diagnostic test for COVID-19 that permits at-home sample collection. Now, patients may use Q-tip-style nasal cotton swabs and saline included in LabCorp's designated self-collection kit – which the company is branding as the "Pixel by LabCorp COVID-19 Test." These samples are...
By Dave Muoio 03:13 pm April 2, 2020
Editor's note: On the same day this story was published, the FDA publicized the first Emergency Use Authorization of a serology test, Cellex Inc.’s qSARS-CoV-2 IgG/IgM Rapid Test. This story has been updated to reflect that development. On Tuesday morning, Los Angeles-based Bodysphere announced that it had received an Emergency Use Authorization (EUA) for a rapid COVID-19 serology test able to...
By Jonah Comstock 04:42 pm April 13, 2017
Nanobiosym, the Cambridge, Massachusetts-based digital health company whose Gene-RADAR scanner won the Nokia Sensing X Prize a few years ago, has been granted Emergency Use Authorization (EUA) from the FDA for its Zika Virus Test.  EUA is a special clearance pathway the FDA uses for devices that address an immediate public health crisis like Zika. Devices authorized under EUA aren’t cleared or...