MedRhythms Granted FDA Listing for InTandem™ (MR-001) to Enhance Walking and Mobility in Adults with Chronic Stroke
Friday, July 07, 2023
MedRhythms has made an announcement regarding the FDA listing of their product, MR-001, which is a neurorehabilitation system aimed at improving walking and ambulation in adults with chronic stroke. The FDA has classified MR-001 as a Class II medical device. The system utilizes Rhythmic Auditory Stimulation (RAS), a well-researched intervention that synchronizes the motor and auditory systems in the brain through external cues like music.
MedRhythms has also revealed the brand name for MR-001 as InTandem™, representing both the synchronization aspect of the device's mechanism and the partnership between the patient and the device.
Stroke is a significant health concern in the United States, with one person experiencing a stroke every 40 seconds according to the CDC. The financial impact of stroke is substantial, exceeding $56 billion between 2018 and 2019. Additionally, reduced mobility is a common consequence for more than half of stroke survivors aged 65 and older, leading to long-term disability.
The FDA listing of InTandem demonstrates MedRhythms' commitment to developing a safe and effective product that complies with FDA guidelines.