Devices

Medtronic Defibrillator Recall is Class 1

FDA has classified as Class 1 a recent Medtronic recall of its Cobalt/Crome implantable cardioverter defibrillators and resynchronization therapy defibrillators due to reports about devices with a short circuit protection alert resulting in reduced-energy electric shock delivery, instead of delivering a second phase of high voltage therapy. “A reduced-energy electrical shock may fail to correct an irregular heartbeat (arrythmia) or may cause an irregular heartbeat,” an FDA recall notice says. “The harms associated with a reduced-energy electric shock or an inaccurate response to an SCP alert may cause serious injury or death.” The agency says there have been 27 complaints, no injuries, and no deaths associated with the issue.

The devices are intended to monitor and regulate heart rate and rhythm. They can deliver a pacing impulse to correct a slow heartbeat (bradycardia), provide biventricular pacing/cardiac resynchronization therapy, or produce an electric shock (cardioversion or defibrillation) to restore a regular heartbeat if a life-threatening arrhythmia occurs.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome