Recall -- Firm Press Release, "Covidien Implements Voluntary Recall of its Pipeline(™) Embolization Device and Alligator(™) Retrieval Device," April 11, 2014.
Clinical Registry Evaluates Vercise Brain Stimulation System for Parkinson's Disease
Boston Scientific has launched a clinical registry to evaluate the Vercise deep brain stimulation (DBS) system for Parkinson's disease. Researchers will follow up to 300 patients implanted with the neurostimulator that targets areas of the brain associated with movement disorders. The device is already sold in Europe, Israel, Australia, and parts of Latin America. In the U.S., the device has investigational approval from the FDA , but is not yet approved for sale.
 Sarvestani, A. "Boston Scientific launches Parkinson's brain stim registry," Mass Device, April 14, 2014.
FDA Approves First Device to Prevent Migraines
FDA has approved Cefaly, the first transcutaneous electrical nerve stimulation (TENS) device to prevent migraine pain. Cefaly is a battery-powered device worn across the forehead that provides mild electrical stimulation to the trigeminal nerve, the nerve which is associated with migraines. According to the device maker, STX-Med, the device is meant to be used once daily for 20 minutes. Although no serious side effects were reported, the user may feel tingling or massaging sensation where the applied electrode touches the skin.
 U.S. National Library of Medicine, NIH, "First Device Approved to Prevent Migraines," HealthDay (March 12, 2014).
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