FDA News Briefs for Wednesday, February 7, 2018February 7, 2018
FDA Expands Indications for Feraheme
The FDA has expanded indications for Feraheme (ferumoxytol injection; AMAG Pharmaceuticals) to include all eligible adults with iron deficiency anemia (IDA) who have intolerance to oral iron or have had unsatisfactory response to oral iron. The agency initially approved Feraheme in 2009 for use only in patients with IDA and current chronic kidney disease. More Information.
FDA Clears Wearable Seizure Monitoring Device
The FDA has granted the Embrace wearable device (Empatica) 510(k) clearance to identify abnormal physiological activity that may be associated with a seizure. The Embrace is a prescription only device that is indicated for use as an adjunct to seizure monitoring of adults in home or health care facilities during periods of rest. The device is worn on the wrist, and senses electrodermal activity and motion detection data to detect patterns that may be associated with generalized tonic clonic seizures in patients with epilepsy or at risk of having epilepsy. When a seizure event is detected, Embrace sends a command to a paired wireless device that is programmed to initiate an alert to a designated caregiver. The system records and stores data from accelerometers, electrodermal activity, and temperature for subsequent review by a trained health care professional. More Information.
FDA Warns of Death and Pulmonary Embolism Related to Extracorporeal Photopheresis
The FDA has sent a letter to healthcare providers describing reports of venous thromboembolism (VTE), including pulmonary embolism (PE), in patients who received autologous immune cell therapy with the CELLEX Photopheresis System (Therakos, Inc.). More Information.