FDA is alerting medical device users about a cybersecurity risk for the Medtronic MiniMed 600 Series Insulin Pump System, including the MiniMed 630G and MiniMed 670G models. There is a potential issue associated with the communication protocol for the pump system that could allow unauthorized access to the pump system. If unauthorized access occurs, the pump’s communication protocol could be compromised, which may cause the pump to deliver too much or too little insulin. The MiniMed 600 series pump system has components that communicate wirelessly. Unauthorized access can occur when a nearby unauthorized person gains access to a pump while it is being paired with other system components.
FDA last week granted accelerated approval to elivaldogene autotemcel (Skysona, bluebird bio), the first cell-based gene therapy indicated to slow the progression of neurologic dysfunction in boys 4–17 years of age with early, active cerebral adrenoleukodystrophy (CALD). Childhood CALD is a life-threatening genetic condition caused by mutations in the ABCD1 gene; these lead to buildup of chemicals that cause inflammation and damage in the brain. The condition affects only males and typically presents with symptoms of inattention, behavior difficulties, and neurologic dysfunction between 4 to 10 years of age. Left untreated, symptoms typically progress to neurologic disability and ultimately death in the second decade of life.