FDA Issues Early Alert on Automated Impella Controller Fixation Issue: What Patients and Hospitals Need to Know The U.S. Food and Drug Administration (FDA) has...
FDA Updates Boston Scientific Defibrillation Lead Recall After 16 Deaths Reported The U.S. Food and Drug Administration (FDA) has issued a correction notice related to...
Boston Scientific Issues New Notice on Accolade Pacemaker Software Update Boston Scientific has issued a new notice about its Accolade family of pacemakers, following a...
Philips Respironics DreamStation Ventilator Recall: Dangerous Programming Errors Put Patients at Risk The U.S. Food and Drug Administration (FDA) has issued another urgent warning involving...
Tandem Diabetes Care Issues Recall of t:slim X2 Insulin Pumps Tandem Diabetes Care, Inc. has announced a voluntary medical device correction involving its t:slim X2...
Artificial intelligence–enabled medical devices (AIMDs) are reshaping U.S. healthcare. They are promising faster diagnoses, improved decision-making, and expanded patient access to advanced technologies. But with...
Abiomed’s Impella Recall and the Future of Cardiovascular Device Innovation When the U.S. Food and Drug Administration (FDA) issues a Class I recall, it signals...
At KBD Attorneys, we have been following the growing crisis surrounding surgical mesh implants—devices often used to treat conditions like hernias, pelvic organ prolapse, or...
Understanding the Different Types of Transvaginal Mesh and How KBD Attorneys Can Help Transvaginal mesh (TVM) devices were introduced to treat conditions like pelvic organ...
