This article was originally published in The Gray Sheet
Implantable electrical neurostimulator gains FDA humanitarian device exemption approval for use in the treatment of patients with chronic nausea and vomiting associated with drug refractory gastroparesis of diabetic or idiopathic origin. The device delivers electrical pulses to nerves in the stomach to treat the gastrointestinal disorder. "Fewer than 4,000 cases of gastroparesis that cannot be controlled adequately with standard medication are diagnosed each year, an incidence rate that fulfilled the FDA's requirements for granting Medtronic an HDE ," Medtronic states
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