Devices

FDA Alert on Pacemaker Interference Caused by Cell Phone

FDA is advising pacemaker and other electronic implant device wearers to keep their cell phones, smart watches and other electronic devices at least six inches away from their implants due to magnetic interference concerns. The safety advisory notes that some consumer electronic devices (cell phones, smart watches) may contain high field-strength magnets, and recent studies have shown that the magnets may cause certain implanted devices to switch to “magnet mode” and suspend normal operations until the magnet is moved away.

The advisory says that many implanted medical devices have patient labeling that cautions patients to keep all cell phones and smart watches at least six inches from the implanted device. “When near high strength magnets, devices with a magnetic safe mode could stop working or change how the device works,” it says. “For example, a cardiac defibrillator may be unable to detect tachycardia events. Or it may change the operational mode of the devices such as turning on asynchronous (i.e., two or more events not happening at the same time) mode in a pacemaker.”

FDA says it has conducted its own testing on some products that use the high field-strength magnet feature and confirmed the magnetic field is strong enough to turn on a device’s magnetic safety mode. It believes the risk to patients is low, and it is not aware of any adverse events associated with the issue at this time.

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