MedRhythms Announces FDA Class II Listing for Movive™ to Support Gait Rehabilitation and Motor Function for Parkinson's Disease

The U.S. Food and Drug Administration (FDA) has classified MR-005, MedRhythms’ digital therapy for walking impairments in Parkinson’s disease, as a Class II medical device. Now branded as Movive, the platform requires a medical prescription and is subject to regulatory controls due to its moderate to high risk classification. MedRhythms plans to launch Movive in select U.S. markets in the coming months. How Movive Works Research shows that rhythm can engage brain areas responsible for movement, helping individuals with Parkinson’s synchronize their gait to external auditory cues. Movive uses rhythmic auditory stimulation (RAS) to improve walking by promoting entrainment, a process where the motor and auditory systems synchronize to a beat. This may enhance neuroplasticity, allowing the brain to form new connections that support long-term mobility improvements. The system includes shoe-mounted sensors that track gait in real time, feeding data to a smartphone app with a proprietary algorithm. The software then adjusts auditory cues from a therapeutic music library to optimize the user’s walking pattern. Clinical Evidence & Patient Benefits A pilot clinical study (NCT04891107) in 24 people with mild to moderate Parkinson’s tested Movive over four weeks. Participants walked 30 minutes, five times a week using the system. Results showed strong adherence, with most completing all 20 sessions, and reported improvements in walking ability, functional mobility, and quality of life. Expanding Digital Therapy for Neurological Conditions Beyond Parkinson’s, MedRhythms is developing digital therapies for other conditions, including multiple sclerosis, stroke recovery, functional neurological disorder, aging, and cognitive issues. With its FDA classification and promising research, Movive represents a new frontier in digital therapeutics, blending music and neuroscience to improve mobility in people with Parkinson’s.