The Medical Device Business Journal — Medical Device News & Articles | MassDevice
Medtronic (NYSE:MDT) said the FDA granted 510(k) clearance for its Affinity Fusion blood oxygenator, used during open heart surgery to replace the function of the lungs.
The Minneapolis-area medical device company, which is the world’s largest pure-play medtech maker, said the Affinity Fusion is designed to filter a patient’s blood to remove particles and air during oxygenation.
Terumo Corp. (TYO:4543) warned users of its Advanced Perfusion System 1, Sarns Modular Perfusion System 8000 and Sarns Perfusion System 9000 of possible malfunctions related to the devices’ air bubble detections systems.
The company has received "multiple reports" of false alarms generated by the air bubble warning system, although it’s a "highly unlikely" malfunction.
ThermalTherapeutic Systems Inc. received clearance from the Food & Drug Administration to begin selling its flagship portable perfusion device, which is used to pump fluid into the abdomen or chest cavity of patients suffering from hypothermia.
FDA clearance of the Veratherm Portable Hyperthermic Perfusion System is a “critical step” for the company, which will begin selling the device next month, according to a press release.
