Music-Based Neurorehabilitation Device for People with PD Receives FDA Nod

The Food and Drug Administration (FDA) has granted Class II listing to Movive (MR-005, MedRhythms, Portland, Maine), a neurorehabilitation device that delivers rhythmic auditory stimulation (RAS) to improve gait and motor function in adults with Parkinson disease (PD). Class II listing is an exemption from FDA premarket notification 510(k) requirements, and according to a statement from MedRhythms, Movive will be available by prescription in Q2 2025.

Movive provides music-based RAS, intended to synchronize movement with rhythmic cues to improve gait speed, balance, and stride length. The device is designed to function autonomously for home-use, with sensors attached to the patient’s shoes to monitor gait and then modify RAS delivery to achieve personalized motor benefit.

The feasibility and preliminary effects of RAS with Movive was assessed in a pilot study (NCT04891107), which included 23 adults with a diagnosis of PD. Primary endpoints included evaluations of patient adherence, safety, patient-reported usability, and improvement in mobility as assessed by Parkinson’s Disease Questionnaire-39 (PDQ-39).

• Participants completed 86.4% of the RAS sessions and 131.1% of the prescribed session duration.
• During sessions, gait speed, stride length, and cadence increased.
• Gait variability decreased during RAS sessions (P<.05).
• After 4 weeks, participants demonstrated improved quality of life, walking endurance, functional mobility, and disease severity (P<.05).

“Movive leverages the well-researched power of rhythmic auditory stimulation (RAS) for people with PD and is the second device to launch from MedRhythms’ proprietary platform,” said Brian Harris, Co-Founder and CEO of MedRhythms. “This is an exciting step for MedRhythms as we advance our mission to use music to address significant mobility challenges for people with neurologic injury and disease, including PD. We look forward to Movive’s potential to support gait rehabilitation in PD, addressing a significant need.”