A Response from Tokos Medical Corporation

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Abstract
SACHS et al. highlight the important and difficult challenge of preventing preterm births. The evaluation of HUAM, however, was made without access to all the data and misrepresents the results of the Physiologic Diagnostic Service study1 that formed the basis for approval of the Genesis system by the FDA. The FDA and the Expert Advisory Panel for Obstetrics and Gynecology exercised extraordinary care in the approval process for this device. They argued that it is unreasonable to expect a diagnostic tool itself to prevent prematurity. Thus, they required that a randomized clinical trial demonstrate that the use of HUAM without . . .

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