Devices

Abbott Expanded Indication for Brain Stimulator

FDA has approved an expanded indication for Abbott’s Infinity Deep Brain Stimulation (DBS) system to include targeting of an area of the brain called the internal globus pallidus (GPi). The company says the GPi plays an important role in motor function and can be targeted with DBS to improve Parkinson’s disease symptoms not adequately controlled by medication. “With this approval, Abbott’s Infinity DBS is now the only directional DBS system approved for all major targets used to treat movement disorders, Parkinson’s disease and Essential Tremor: the subthalamic nucleus, ventral intermediate nucleus and GPi,” it says.

The device can be operated on an iOS software platform with Bluetooth wireless technology. “Clinicians can streamline the programming process with an iPad mini device using Abbott’s new Informity Programming feature to become more efficient in their practice and achieve optimal outcomes with directional leads,” the company says. Patients can also manage their symptoms with the Infinity DBS System iPod touch controller, it adds.

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