Fetal device HDE
This article was originally published in The Gray Sheet
Executive Summary
FDA granted a humanitarian device exemption to California-based Karl Storz Endoscopy America for its TTTS Fetoscopy instrument set, announced April 3. The product is used to treat fetuses with twin-to-twin transfusion syndrome, a rare condition in which blood flows unevenly through identical twins' shared blood vessels in the placenta. The fetoscope allows visualization of the fetus, while a laser can be passed through a sheath to normalize blood flow...