Wearable technology designed to treat depression has won a “breakthrough device” designation from the U.S. Food and Drug Administration.
The Relivion system, developed by Neurolief, is a non-invasive multi-channel brain neuromodulation technology. It is designed as an additional treatment to pharmaceutical management of major depressive disorder in adults who have not achieved satisfactory improvement from antidepressant medications, a news release said.
Gaining FDA recognition bolsters an upcoming study on Relivion, said Chris Richardson, chairman of Neurolief, an Israeli company with U.S. operations in Tampa. He called the move a major milestone for Neurolief.
The Relivion is a neurostimulation device similar to a headset that the patient places on their head to administer treatments in the comfort of their own home. It stimulates the release of neurotransmitters in the brainstem and modulates brain networks associated with mood control, by transferring mild electrical pulse to the brainstem. It is used in tandem with a smartphone app and a cloud database so doctors can remotely monitor patients, analyze the data and personalize treatments to enhance treatment outcomes.
Ninety percent of patients with major depressive disorder who did not respond to previous pharmaceutical treatment showed improvement when using Relivion, the news release said.
In the same study, 37 percent of patients reached full remission from their depressive episodes, according to the release.
The FDA’s breakthrough device program is designed to provide patients and healthcare providers with timely access to transformative medical devices by speeding the development, assessment, and review of innovative medical devices.