We previously reported a decision by the U.S. Food and Drug Administration (FDA), denying the premarketing authorization of several ...

A warning letter ... FDA inspection last year of Dexcom’s facilities in San Diego and Mesa, Arizona. Marcus wrote that after the FDA requested additional information and a separate 510(k ...

“The FDA has reviewed our submission and determined that it substantially meets the requirements for approval: the FDA’s Approvable Letter included ... This decision does not impact Genio's ...

(RTTNews) - Daxor Corporation (DXR), Thursday announced the submission of its next-generation blood volume analyzer - Daxor BVA - to the Food and Drug Administration (FDA). The company says that ...