FDA Approves Humanitarian Device Exemption for Treatment of Fetuses With Twin-To-Twin Transfusion Syndrome
The Food and Drug Administration (FDA) has announced the approval of a Humanitarian Device Exemption (HDE) for Fetoscopy Instrument Sets distributed by Karl Storz Endoscopy America, Inc., Culver City, Calif. under the Humanitarian Use Device (HUD) program for the treatment of fetuses with twin-to-twin transfusion syndrome (TTTS).