MedRhythms' Movive™ Gains FDA Class II Status for Parkinson's Gait Rehabilitation

MedRhythms, a company based in Portland, Maine, has recently announced a significant advancement in neurorehabilitation technology with the FDA's classification of its new system, MR-005, as a Class II, prescription-only medical device. This innovative system, now branded as Movive™, is specifically designed to aid in the rehabilitation of gait and motor functions in adults affected by Parkinson's disease (PD).

Brian Harris, the Co-Founder and CEO of MedRhythms, highlighted the importance of Movive™, which utilizes rhythmic auditory stimulation (RAS), a well-researched method in neurologic rehabilitation. The introduction of Movive™ marks the second major device launched from MedRhythms' unique technology platform. Harris emphasized the company's dedication to addressing mobility challenges faced by individuals with neurologic injuries and diseases, particularly Parkinson's disease, and expressed optimism about Movive™'s potential to significantly improve gait rehabilitation for those living with PD.

Parkinson's disease is currently the fastest-growing neurodegenerative disorder globally, affecting nearly one million people in the United States alone, including 110,000 veterans. It ranks as the second most prevalent neurodegenerative disease. Key symptoms of PD include impairments in gait and motor functions, with walking difficulties cited as the most common challenge reported by patients. While RAS and other forms of neurologic music therapy have been established as effective strategies for motor and gait rehabilitation in Parkinson's patients, their application has often been hindered by limited accessibility.

The Movive™ system is designed to overcome these barriers by providing individualized and adaptive RAS therapy directly in the patient's home, thereby expanding access to this beneficial intervention. The device is anticipated to be available in select U.S. markets in the second quarter of 2025.

Besides Movive™, MedRhythms has been at the forefront of developing next-generation neurotherapeutics aimed at enhancing mobility and other related functional outcomes through a patented platform that integrates sensors, software, and music, combined with advanced neuroscience. This platform has been established in collaboration with Universal Music Group and is intended to target the neural pathways associated with motor function. MedRhythms is actively working on a series of digital therapeutics intended for various neurological conditions, such as stroke and multiple sclerosis, alongside Parkinson's disease.

Previously, MedRhythms' product for chronic stroke walking deficits received the Breakthrough Device Designation in 2020. The company also completed a Series B financing round in 2021, led by Morningside Ventures and Advantage Capital, to support its innovative endeavors.

The unveiling of Movive™ represents a promising advancement in the field of neurorehabilitation, particularly for those affected by Parkinson's disease. With an eye towards addressing significant mobility challenges, MedRhythms continues to pioneer the development of music-based therapeutic solutions designed to enhance the quality of life for individuals with neurological conditions.