News & Press
UK MHRA clears Flow Neuroscience tDCS device for treatment-resistant depression — Europe already cleared
Medscape UK3/31/2026·03/31/26🌐 Europe
Summary
The UK Medicines and Healthcare Products Regulatory Agency granted CE mark equivalent clearance to Flow Neuroscience's tDCS headset and app combination for treatment-resistant depression, following its existing CE mark in the EU. Flow is now cleared in 31 European countries and positions the UK clearance ahead of their planned US FDA pivotal trial read-out.
Why it matters
UK MHRA clearance post-Brexit requires separate review from EU CE, making this a meaningful regulatory milestone. With Europe fully cleared, Flow is now building the global evidence base to support their FDA filing.
#Depression#Europe#Neurostimulation#UK#tDCS
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