FDA Safety Alert: Medtronic HVAD Pump Implant Kits

The Food and Drug Administration (FDA) has announced a recall of specific lots of the Medtronic HVAD pump implant kits due to a possible delay or failure to start. The HeartWare Ventricular Assist Device (HVAD) pump implant kit is part of the HeartWare HVAD System,...

FDA Issues EUA for Third COVID-19 Vaccine

The Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the Janssen COVID-19 vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) for use in...

FDA Approves Targeted Treatment for Rare DMD Mutation

The Food and Drug Administration (FDA) has granted approval for Amondys 45 (casimersen; Sarepta Therapeutics Inc.) injection for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 45...

FDA Safety Alert: Medtronic Valiant Navion

The Food and Drug Administration (FDA) has announced a voluntary recall of unused Medtronic Valiant Navion thoracic stent graft systems. The Valiant Navion thoracic stent graft system is indicated for the endovascular repair of all lesions of the descending thoracic...