We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA issued a warning yesterday about the risk of false results from noninvasive prenatal screening (NIPS) tests, also known as cell-free DNA tests or noninvasive prenatal tests. Read More
Frisco, Tex.-based InspectIR Systems has gained the FDA’s first Emergency Use Authorization (EUA) for an affordable breath-based diagnostic test for COVID-19 infection, and other companies are working on similar analyzers for the pandemic disease. Read More
Gauthier Biomedical, a spinal and orthopedic surgical instrument manufacturer in Grafton, Wisc., has received a five-observation Form 483 from the FDA following an inspection in which the agency’s investigator observed several repeat deficiencies from a previous inspection in 2016. Read More