(Photo by Sundry Photography/Getty Images)
March 29, 2021
On Thursday, Amazon landed an FDA Emergency Use Authorization for its COVID-19 test kit with at-home sample collection.
According to FDA documents, the product is cleared for self-sample collection by nasal swab for individuals aged 18 years and over. The kit can be used either under the supervision of a healthcare provider or unsupervised at home. The kit includes a nasal swab, a collection tube...
March 5, 2021
The FDA has issued its first emergency use authorization for a COVID-19 molecular diagnostic test that does not require a prescription and can be used at home.
Developed by Cue Health, the Cue COVID-19 Test for Home and Over the Counter Use was first authorized for point-of-care use last June.
It uses a nasal swab sample collected from the lower nose to detect the presence of SARS-CoV-2 RNA, and...
December 15, 2020
The U.S. FDA announced today an Emergency Use Authorization for the first over-the-counter COVID-19 diagnostic test for home use.
Developed by Australian digital diagnostics company Ellume Health, the single-use kit is accompanied by a Bluetooth-connected app that guides users through the testing process and automatically reports its results for disease monitoring.
The test returns its results in...
November 18, 2020
Yesterday afternoon, the U.S. FDA issued an Emergency Use Authorization (EUA) to a COVID-19 molecular diagnostic test that provides individuals with a result within 30 minutes, in the comfort of their home.
As opposed to currently available at-home testing products, which have patients self-collect a nasal swab sample and ship it for processing in a lab, the Lucira COVID-19 All-in-One Test Kit...
October 6, 2020
The FDA has issued an Emergency Use Authorization (EUA) to a clinical decision support (CDS) tool that predicts when an adult patient admitted to the hospital with COVID-19 is at risk of further complications.
Developed by Oakland, California-based diagnostic algorithm developer Dascena, the COViage Hemodynamic Instability and Respiratory Decompensation Prediction System reviews demographic and...
July 27, 2020
On Friday evening, the FDA reissued an emergency use authorization (EUA) for LabCorp's COVID-19 RE-PCR Test that now allows for testing among those without any symptoms of COVID-19.
The agency also expanded the indication to allow for pooled sample testing – a technique of combining multiple samples into a single test, and then following up with individual tests should the group be positive. The...
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...
May 8, 2020
Just a few hours ago the FDA greenlighted the first home-collected saliva sample for COVID-19. Rutgers Clinical Genomics Laboratory, which already landed an EUA in mid-April for its test, can now expand its efforts to include test kits for home collection.
Patients do so using a specially designed collection device. This sample is then sent off to the Rutgers Clinical Genomics Laboratory in a...
May 5, 2020
The FDA has granted an Emergency Use Authorization (EUA) to VitalConnect that allows its VitalPatch wearable sensor to further monitor patients undergoing COVID-19 treatment.
As per the agency's letter of authorization, providers may use the remote-monitoring device in a hospital setting to spot changes in patients' QT interval, which may be dangerously prolonged by experimental drug treatments...