OCD Indication Approved For Brainsway TMS Device

US FDA used its de novo review pathway to approve Brainsway Ltd.’s Brainsway Deep Transcranial Magnetic Stimulation System to treat obsessive compulsive disorder.

Transcranial magnetic stimulation can now be used for obsessive compulsive disorder, US FDA said in its Aug. 17 approval of the Brainsway Deep Transcranial Magnetic Stimulation System.

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Draft FDA Reorganization Would Unite All Product Centers

 

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Now that a federal judge has ruled the US FDA exceeded its authority by unilaterally assuming regulatory oversight of lab-developed tests, what’s the agency’s next move? And does it really have one?

Pushing On An Open EU Door? Time For MHRA To Get Practical About UK’s Regulatory Ambition

 
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