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FDA Clears Brainsway TMS System to Treat OCD
August 20, 2018
On Friday, the FDA said it granted de novo approval for Brainsway‘s deep transcranial magnetic stimulation system, now indicated for treating obsessive compulsive disorder.
The TMS system uses magnetic fields to simulate nerves in the brain, and has been shown to reduce the severity of OCD in patients.
A 100-patient randomized, multi-center study of the device indicated that patients who received TMS treatment alongside medical management had a higher response rate, at 38%, than those treated with medical management and a sham device, at 11%.
The most frequent adverse reaction was headache, which was reported by 37.5% of patients who received treatment with the Brainsway device and 35.3% of patients who received sham treatment. No serious adverse reactions were reported and other adverse reactions, including application site pain or discomfort, jaw pain, facial pain, muscle pain, spasm or twitching and neck pain were reported as mild or moderate and resolved shortly after treatment, according to the FDA.
Read More at the Source: Brainsway wins FDA nod for OCD-treating TMS system – MassDevice
By: Fink Densford
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