Dr. Palter over at Docinthemachine, has an excellent piece about the FDA’s humanitarian device exemption (HDE) program, and how it has recently approved Karl Storz Fetoscopy Instrument Sets for the treatment of twin-to-twin transfusion syndrome (TTTS).
FDA Humanitarian Device Approval for Fetal Surgery
December 28th, 2006 
Josh Umbehr Ob/Gyn, Surgery