Neurolief Gets Breakthrough Designation for Depression Neuromodulator

Neurolief has received a Breakthrough designation from the FDA for its Relivion DP system, a wearable neuromodulator for the treatment of major depressive disorder (MDD).

The non-invasive device is designed to be used in combination with drugs to treat the disorder in adults who have not adequately responded to pharmaceuticals alone.

In a clinical trial, ninety percent of MDD patients who did not adequately respond to a pharmaceutical treatment showed improvement when using the device, and 37 percent of patients achieved full remission from their depressive episodes, the company said.