Software continues to be a key factor in recalls, and this year the end of some EUAs may also contribute to an increase.
The test generates results within 20 minutes and can be used by adults and children over the age of two years old.
The record-high number of authorizations last year was a significant jump over 2019.
With the accelerated adoption of many new technologies, ECRI’s annual health technology hazards list has been transformed by the COVID-19 pandemic.
Patients will be able to collect their own samples and ship it to a Quest Diagnostics lab for analysis.
A review of new, successful treatment options for the novel coronavirus.
Lucira Health’s single-use molecular test kit will be available for prescription home use in people age 14 and older.
Part three of this series discusses the key defenses available to each element of a lawsuit against providers and labs.
The serology test is the first of its kind to detect neutralizing antibodies from a recent or prior SARS-CoV-2 infection.
The agency stated that Battelle Memorial Institute is not in compliance with reporting requirements related to its CCDS.