Devices

Abbott Recalls Proclaim Pulse Generators

Abbott is recalling (Class 1) its Proclaim and Infinity implantable pulse generators (IPGs) due to complaints from patients who are unable to exit MRI mode. The Patient Controller (iPhone/iPod) may lose the ability to communicate with its IPG while in MRI mode, a recall notice says. It adds that many situations where this has occurred involved a recent operating system update on the Patient Controller that caused the IPG to be deleted from the list of available Bluetooth devices on the controller.

The Proclaim neurostimulation devices are intended to deliver low-intensity electrical impulses to nerve structures. The Proclaim XR and Proclaim Plus devices are used for spinal cord stimulation, the Proclaim DRG is used for dorsal root ganglion stimulation, and the Infinity IPG is used for deep brain stimulation.

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