Coral Springs, Florida–based Neurolief describes Proliv Rx as the first prescription, physician-directed at-home neuromodulation therapy that serves as an adjunctive treatment for adults with major depressive disorder (MDD) who failed to achieve satisfactory improvement from at least one previous antidepressant medication.
The FDA granted the device premarket approval (PMA), with clinical evidence from the MOOD study supporting the nod.
Neurolief said in a news release that the approval offers a scalable next-step therapy when medications fail. It enables clinically validated brain neuromodulation at home under physician oversight.
Proliv Rx delivers focal, multi-channel, external combined occipital and trigeminal afferent stimulation (eCOT-AS) therapy. It applies gentle electrical pulses to targeted neural pathways associated with depression without invasive procedures. The technology also delivers low risks related to systemic side effects.
Using three adaptive output channels, the device non-invasively transfers electrical pulses to the brainstem through major neural pathways in the head. The pathways conduct the electrical stimulation to the brainstem and higher brain regions involved in depression. Proliv Rx’s interface features cloud-enabled data-tracking features and AI integration. The setup allows physicians to monitor patients, analyze their data and personalize treatment, enhancing therapy outcomes.
Neurolief expects to make the system available in the U.S. in early 2026 through authorized prescribers.
“Proliv Rx was developed to extend brain neuromodulation beyond the limitations of traditional clinic-based care,” said Scott Drees, CEO of Neurolief. “Patients who don’t respond adequately to antidepressants face practical barriers to accessing clinic-based therapy. We are excited to make this therapy available to physicians and their patients.”
BrainsWay invested in Neurolief with an option to buy in August 2025.
