An EU Notified Body has classified Flow as a medical device intended for use as a treatment for depression. In Europe, Flow is classified as a class IIa medical device. All manufacturers of medical devices in class IIa in Europe are subject to assessments and audits performed at regular intervals by a so-called notified body.
What is Flow?
Flow is a medical grade headset and therapy app designed to treat depression. It is the first of its kind available in Europe to buy and use at home. In Europe, Flow is classified as a class IIa medical device. Flow is suitable for people 18 years of age or older.
How does it work?
The Flow headset uses Transcranial Direct Current Stimulation (tDCS) which offers a gentle electrical signal to stimulate the left frontal cortex and rebalance neural activity in this part of the brain. During this process, the user interacts with a virtual therapy app which provides information and advice on lifestyle changes, including improved sleep, nutrition, meditation and exercise.
The Flow headset uses a brain stimulation technique called tDCS (short for transcranial direct current stimulation). tDCS has been researched for many different conditions over the last 20 years. The results of these studies indicate that tDCS has approximately the same effect as antidepressant medication – but with fewer and less-severe side effects. The results in the latest randomised controlled trial (RCT) study on 245 patients shows that 41% of the patients had a 50% reduction or more in their depression symptoms.