The company can now begin a pivotal study of the medical device with the IDE.

Helsinki, Finland–based Sooma designed the tDCS device to treat depression through portable neuromodulation. Worn as a cap, the device uses a non-invasive technique that stimulates the brain with a mild electrical current. This can alleviate depression symptoms without the need for pharmaceuticals.

Sooma’s prescription-only therapies can work as a standalone treatment or in combination with other treatment types. The company says it’s also one of the few brain stimulation therapies patients can safely use at home.

The technology won FDA breakthrough device designation just over two years ago. Sooma says that, with its IDE study, it now seeks full FDA approval for the device. The device already has clearance to treat MDD in 35 countries worldwide.