FDA Authorizes Use of Pediatric Device to Treat Esophageal Birth Defects
The FDA authorized the use of Cook Medical’s Flourish device to treat infants up to one year old for esophageal atresia, a birth defect that causes a gap in the esophagus.
The device uses magnets to pull the upper and lower esophagus together.
The agency granted the device authorization under the Humanitarian Device Exemption. — Cynthia Jessup