Royal Philips NV has been handed a health care policy order requiring it to recall and replace 277,500 defective respiratory therapy devices in France within four months. Twelve ranges of respiratory device for patients who depend on mechanical breathing assistance as well as continuous positive airway pressure devices used to treat sleep apnea, have been affected by a design issue.
Case Western Reserve University spinout Synapse Biomedical Inc. has received emergency use authorization from the U.S. FDA for its Transaeris diaphragm pacing system (DPS) device to prevent and treat ventilator-induced diaphragm dysfunction (VIDD).