Fetal heart monitor approval
This article was originally published in The Gray Sheet
Executive Summary
Swedish firm Neoventa is looking for a U.S.-based partner to help market the STAN S31 fetal heart monitor, after announcing PMA approval Nov. 2. FDA's Obstetrics and Gynecology Devices Advisory Panel unanimously recommended approval of the device, with conditions, at a June 23 meeting (1"The Gray Sheet" June 27, 2005, p. 15). Besides modifying the device for easier use by American clinicians, FDA is also requiring Neoventa to distribute educational materials with the device...
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