Net Medical Xpress Solutions, Inc. (NMXS)

[greasemonkeyshoes]

education brief: Marketing Authorization Using the De Novo Review Pathway....
pertaining to FDA 510(k) and BioFire Respiratory Panel 2.1 (RP2.1).
https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-sars-cov-2-diagnostic-test-using-traditional-premarket-review-process
my favoriet:
"it is the first SARS-CoV-2 diagnostic test that will be permitted to be marketed beyond the public health emergency."
"The grant of the De Novo request for this test is based on additional data showing validation beyond what is needed for emergency use authorization. The FDA reviewed data from a clinical study of more than 500 test samples and a variety of analytical studies, which demonstrated a reasonable assurance that the BioFire RP2.1 was safe and effective at identification and differentiation of various respiratory viral and bacterial pathogens. "