eNeura, a company out of Baltimore, Maryland, received FDA 510(k) clearance for its SpringTMS device to treat migraine headaches. The device delivers transcranial magnetic stimulation, hence the TMS in the product name, in order to disrupt the electrical signals that are thought to be responsible for migraines.
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The SpringTMS is intended for patients to use on their own, positioning the device behind the head and activating a single pulse using buttons on the handles. In published studies, the device has shown effectiveness similar to available medications but without any serious side effects. It already received European CE mark of approval and is available in the UK for migraine treatment and prevention.
From the announcement regarding what led to the FDA clearance:
The FDA reviewed a double-blind, placebo-controlled, randomized clinical study of 201 patients. The study, which took place in 18 U.S. centers, showed that nearly 38 percent of subjects who used sTMS when they had migraine headache pain were pain-free two hours after using the device compared to approximately 17 percent of patients in the control group. After 24 hours, approximately 34 percent of the sTMS users were pain-free compared to only 10 percent in the control group. The treatment did not produce any device-related serious adverse events.