FDA Grants Expedited Access Pathway to MyoRegulator PM-2200 System
The FDA has granted Expedited Access Pathway designation and priority processing status to neuromodulation company PathMaker Neurosystems for its MyoRegulator PM-2200 system.
The device is being developed for the treatment of muscle spasticity found in patients with stroke, cerebral palsy, multiple sclerosis, spinal cord injury, traumatic brain injury and other neurological conditions.
Featuring PathMaker’s proprietary DoubleStim technology, MyoRegulator is provides simultaneous non-invasive stimulation at spinal and peripheral locations.
The FDA has granted the device an Expedited Access Pathway designation because it is intended to treat an irreversibly debilitating condition and because it offers significant advantages over existing alternatives, which are said to offer short-term efficacy at best. — Michael Cipriano