Neurolief announced today that it received FDA breakthrough device designation for its Relivion DP system for treating major depression.
Relivion is a wearable, non-invasive, multi-channel brain neuromodulation device designed as an adjunctive treatment to pharmaceutical management of major depressive disorder (MDD) in adults who haven’t experienced satisfactory improvement from antidepressant medications, according to a news release.
Netanya, Israel-based Neurolief’s Relivion DP is a headset-like device placed on the head to stimulate the release of neurotransmitters in the brainstem and modulate brain networks associated with control of mood. The device transfers mild electrical pulses to the brainstem via six branches of the occipital and trigeminal nerves and can be used in tandem with its smartphone app and a cloud database that allows for remote monitoring and care.
“Gaining FDA recognition of our potential to substantially impact an area of unmet need bolsters our upcoming Relivion DP major depression pivotal study, and brings us one step closer to reaching people who desperately need this new treatment,” Neurolief chairman Chris Richardson said in the news release. “This categorization is a major milestone for Neurolief, and we hope to one day make a significant difference for patients suffering from depression.”
Original Article: (https://www.massdevice.com/neurolief-wins-fda-breakthrough-nod-for-wearable-neuromod-for-depression/)