MedRhythms today announced that MR-001, the company’s evidence-based neurorehabilitation system to improve walking and ambulation in adults with chronic stroke walking deficits, has been listed as a Class II medical device with the U.S. Food and Drug Administration (FDA).
| Stroke is a leading cause of long-term disability, and over half of people aged 65 or older who have had a stroke experience reduced mobility and gait deficits PORTLAND, Maine, July 6, 2023 /PRNewswire/ -- MedRhythms today announced that MR-001, the company’s evidence-based neurorehabilitation system to improve walking and ambulation in adults with chronic stroke walking deficits, has been listed as a Class II medical device with the U.S. Food and Drug Administration (FDA). The system delivers an intervention based on the principle of Rhythmic Auditory Stimulation (RAS), a well-researched clinical intervention utilizing the mechanism of auditory-motor entrainment, through which the motor and auditory systems in the brain subconsciously synchronize to an external cue, such as music.
MedRhythms also unveiled the brand name for MR-001: InTandem™. The InTandem name reflects both the synchronization inherent in the device’s mechanism of action and the partnership formed between patient and device. “Today is a historic day for MedRhythms and an essential accomplishment as we work to bring a new care solution to the 3.5 million people who struggle with mobility and independence long after the incidence of a stroke,” said Brian Harris, CEO and Co-Founder of MedRhythms. “During my time as a clinician at Spaulding Rehabilitation Hospital, I saw the positive impact that standardized interventions using music could have on the mobility of my patients. I am honored and proud that our team has committed to our mission of translating these interventions into evidence-based medical devices that can be utilized in home settings, breaking down several historic barriers to access. This important milestone enables the world’s first prescription music platform, and is a remarkable day for our company, for music, for healthcare, and most importantly for stroke survivors.” Every 40 seconds, a person in the United States experiences a stroke, according to the Center for Disease Control (CDC), and the total financial impact of stroke in the United States exceeded $56 billion between 2018 and 2019. The burden on patient functioning is also profound. More than half of stroke survivors aged 65 and older experience reduced mobility, and stroke has become a leading cause of long-term disability. InTandem, which is designed to be used independently by a patient in a home setting, received Breakthrough Device Designation from the FDA in 2020. Earlier this year, MedRhythms announced successful completion of a pivotal clinical trial for InTandem. “The listing of InTandem demonstrates MedRhythms’ unwavering commitment to developing a safe, effective product that adheres to the stringent guidelines set forth by the FDA,” said Danielle Parker, Head of Regulatory and Quality at MedRhythms. “As we prepare for the next phase of InTandem’s product life cycle, we remain committed to meeting the needs of our patients while upholding the highest quality standards.” InTandem is anticipated to be available soon in select market segments. Media Inquiries: press@medrhythms.com About MedRhythms Forward-Looking Statements
SOURCE MedRhythms |
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