Posted by Michael Wonder on 13 May 2017
FDA authorises use of new device to treat oesophageal birth defect in babies
12 May 2017 - The U.S. FDA today authorised use of the Flourish Pediatric Esophageal Atresia Anastomosis, a first-of-its-kind medical device to treat infants up to one year old for a birth defect that causes a gap in their oesophagus, called oesophageal atresia.
The FDA reviewed data for the Flourish device through the humanitarian device exemption (HDE) process. A Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects not more than 8,000 individuals in the U.S. per year.
