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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
The company is planning additional 510(k) submissions for the system for use in remote patient monitoring of electrolytes, fluid management and fistula status. Read More