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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...
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