The FDA today said it will allow the 1st prosthetic arm to translate muscle signals into action onto the U.S. market under its de novo protocol for innovative devices. The prosthesis, called the DEKA arm system, was developed by inventor Dean Kamen’s DEKA Integrated Solutions.
The DEKA arm "can perform multiple, simultaneous powered movements controlled by electrical signals from electromyogram (EMG) electrodes," the FDA said. The electrodes sense electrical activity in muscles near the prosthesis and send signals to a processor that translates them into movement, according to a press release.
The device, which is the same shape and weight as a human arm, can convert the signals into up to 10 powered movements, according to the federal watchdog agency. The DEKA arm can be configured for limb loss at the shoulder joint, mid-upper arm or mid-lower arm; it can’t be configured for limb loss at the elbow or wrist joint, the FDA said.
“This innovative prosthesis provides a new option for people with certain kinds of arm amputations," Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices & Radiological Health, said in prepared remarks. "The DEKA arm system may allow some people to perform more complex tasks than they can with current prostheses in a way that more closely resembles the natural motion of the arm."
The FDA’s de novo classification process is aimed at 1st-of-a-kind, low- to moderate-risk devices. In granting the DEKA arm decision, the agency said it reviewed data from a 36-patient study by the U.S. Veterans Affairs Dept. that examined the arm’s performance "in common household and self-care tasks." About 90% of the participants were able to perform previously impossible tasks such as unlocking doors, preparing food and feeding themselves, using zippers and brushing or combing their hair, according to the release.