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.
From the press release:
“As we find ourselves in the midst of a large and growing global mental health crisis, more and more patients are in need of effective options that lack the short and long-term side effects we see with traditional treatments,” said Linda Carpenter, MD, a Professor of Psychiatry and Human Behavior in the Warren Alpert Medical School at Brown University. As per Dr. Carpenter, “Based on its efficacy and safety profile, RelivionDP® could be the answer for the approximately 40% of patients with depression who do not respond to standard medication and psychotherapy treatments. The fact that it’s also wearable, allows for a personalized level of treatment, and has remote monitoring capabilities makes this an extremely attractive option for patients with major depression.”
The Breakthrough Devices Program was established by the FDA to provide patients and healthcare providers with timely access to transformative medical devices by speeding the development, assessment, and review of innovative medical devices.
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