A U.S. government contract is expected to accelerate the development, validation, and FDA clearance of Cue Health's portable, molecular diagnostic test to detect SARS-CoV-2, the virus that causes COVID-19, in less than 25 minutes using a simple...
The new five-minute test is the second Abbott test to receive emergency use authorization by FDA for COVID-19 detection. Combined, Abbott expects to produce about 5 million tests a month.
Nefertiti Brown, MD, an attending physician in California, was tested for COVID-19 on March 18 after displaying symptoms of the virus.
Step-by-step recommendations from FDA on how to seek emergency use authorization (EUA) for COVID-19 tests, ventilators, and personal protective equipment, plus answers to frequently asked questions.
Here’s what was new in the world of medical device suppliers during the week of March 22, with many suppliers responding to needs in light of the COVID-19 pandemic.
The CE mark comes as the virus continues to rage through Europe. Italy has been decimated by COVID-19, with a death toll of about 7,503 people. However, current reports show the number of new cases in Europe is declining for the fourth day in a row.
FDA issued a letter to the medical device industry regarding steps the Center for Devices and Radiological Health has taken to prioritize work that advances the United States response during the coronavirus public health emergency.
The Abbott Park, IL-based company said it would deploy about 150,000 laboratory tests immediately and wanted to ramp up production to one million tests per week by the end of the month.
In addition to increasing production of its collection devices, BD worked with BioGX Inc. to request an FDA Emergency Use Authorization for a new COVID-19 diagnostic.