Relivion DP is a non-invasive multi-channel brain neuromodulation technology for the treatment of major depression
Medical neurotechnology company Neurolief has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its Relivion DP system to treat major depression.
Relivion DP is a non-invasive multi-channel brain neuromodulation technology for the treatment of major depression.
Relivion DP is a wearable device that can be used as an adjunctive treatment for the pharmaceutical management of major depressive disorder (MDD) in adults who have not reached satisfactory improvement from antidepressant medications.
According to the company, the Relivion DP is a neurostimulation device similar to a simple headset, which can be placed on the patient’s head to administer treatments as per the convenience at the home.
The device will help treat major depression by stimulating the release of neurotransmitters in the brainstem and modulating brain networks linked with control of mood.
Relivion DP system will help remotely monitor patients and analyse their data to provide suitable treatments
With the support of three adaptive output channels, the device transfers electrical pulses to the brainstem through six branches of the occipital and trigeminal nerves, which are responsible for sensation in the face, ears, and scalp.
Relivion DP system, which is part of a digital therapeutics platform, is used in tandem with its smartphone app and a cloud database to help physicians remotely monitor patients, analyse their data, and personalise treatments.
Neurolief chairman Chris Richardson said: “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.
“This categorisation is a major milestone for Neurolief, and we hope to one day make a significant difference for patients suffering from depression.”
In July 2019, Neurolief secured CE mark approval for its Relivion non-invasive and adaptive neuromodulation digital treatment for migraine.