Medtronic touts FDA 510(k) clearance for its lung support system for neonate, infant and pediatric patients.

Medtronic (NYSE:MDT) won FDA 510(k) clearance for its Affinity Pixie Oxygenation System, a lung-support device for use on neonatal, infant and pediatric patients undergoing open-heart surgery.

The device routes blood away from the child's heart and through a bypass circuit that removes carbon dioxide, adds oxygen and warms or cools the blood to match a desired body temperature before returning it to the body, according to a press release.