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DURHAM, N.C., Nov. 9, 2022 /PRNewswire/ -- Baebies has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its rapid, point-of-c...
Theranos was able to market its tests without FDA approval because of a loophole that allows lab-developed tests to be used and advertised. These tests have a lower level of oversight.