The US Food and Drug Administration (FDA) has listed MedRhythms’ InTandem (MR-001) neurorehabilitation system as a Class II medical device.
The US-based digital therapeutics company has designed MR-001 to improve walking and ambulation in adults with chronic stroke walking deficits. It is intended to be used independently by a patient in a home setting.
The system is based on the principle of Rhythmic Auditory Stimulation (RAS), a clinical intervention that has undergone extensive research.
RAS uses an auditory-motor entrainment mechanism, which causes the motor and auditory systems in the brain to unconsciously sync up in response to an external cue like music.
MedRhythms announced InTandem as the brand name for the MR-001. The brand name refers to the partnership that develops between the patient and the device as well as the synchronisation that is built into the device’s mechanism of action.
MedRhythms CEO and co-founder Brian Harris said: “I am honoured and proud that our team has committed to our mission of translating these interventions into evidence-based medical devices that can be utilised 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.”
InTandem was granted Breakthrough Device Designation by the FDA in 2020. The digital therapeutics company reported the successful conclusion of a key clinical trial for the neurorehabilitation system earlier this year.
MedRhythms regulatory and quality head Danielle Parker said: “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.
“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.”
