Myomo, Inc., a Boston, Mass company, is reporting that its “smart” portable elbow brace, the Myomo e100 NeuroRobotic System, has just been 510(k)’ed by the FDA. With the approval to market its device in the US, the company is looking to tap into a large market of status post stroke sufferers, to “allow patients to self initiate and control movement of partially paralyzed limbs using their own biological signals.” The noninvasive system is also designed to help in the rehabilitation process of patients by “engaging and reinforcing both neurological and motor pathways,” according to the company. We have covered this device a while back, when it was in the prototype stage, being developed at MIT. (See: NeuroRobotic Brace for Stroke Recovery.)
Details about the technology:
Designed as a feedback-based, closed loop system, NeuroRobotics facilitates muscle re-education by both amplifying and rewarding a patient with desired motion in concert with his or her own muscular activation.
Key system components include: surface electromyography (EMG) sensing, system software, and wearable, portable robotic devices. Since movement is initiated and continuously controlled by an individual’s residual muscle activity, the person’s brain functions as the system controller. With this capability, patients have an opportunity to stop, in real time, during execution of a targeted training task, to evaluate performance and re-adjust positioning, as they train toward muscle re-education. The goal is that through repetition and practice, patients will relearn and achieve more normative movement patterns.
How it Works
Patient’s brain is the controller: When a patient attempts movement during therapy, their muscles contract and electrical muscle activity signals fire Non-invasive sensing: An EMG sensor sits on the skin’s surface to detect and continuously monitor a person’s residual electrical muscle activity Proprietary system software: Advanced signal processing software filters and processes the user’s EMG signal, and then forwards the data to a robotic device Proportional assistance: Portable, wearable robotics use the person’s EMG signal to assist with desired movement; power assistance is customized to patient ability with Myomo’s real-time adjustable control unit.
Product page: Myomo e100 NeuroRobotic System …
Press release: Myomo Receives FDA Clearance to Market the Myomo e100 NeuroRobotic System (.pdf)
Flashbacks: NESS H200™ System; Ankle Brace to Prevent Falls ; Device to Aid People With Muscular Dystrophy; Anklebot for Stroke Patients; Functional Electrical Stimulation Shows Promise.