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FDA Approves First MRI-Guided Ultrasound Device to Treat Essential Tremor

The FDA recently approved INSIGHTEC’s Premarket Approval (“PMA”) application for ExAblate Neuro, a device designed to treat essential tremor. Essential tremor is the most common kind of tremor; it commonly affects the hands,...more

7/14/2016  /  FDA Approval , Medical Devices

FDA Medical Device Quality Inspections Drop in 2015

The U.S. Food & Drug Administration (FDA) has released statistics showing that it inspected fewer medical device manufacturers in 2015 than in 2014....more

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