DEKA Integrated Solutions has received FDA marketing approval for the DEKA Arm System, the first prosthetic arm that can perform multiple, simultaneous powered movements controlled by electrical signals from electromyogram (EMG) electrode in individuals with upper extremity amputations occurring at the shoulder joint, mid-upper arm, or mid-lower arm.
The DEKA Arm System allows individuals to perform more complex tasks in a way that is more closely aligned with natural arm motions, compared to other prosthetics. EMG electrodes in the DEKA Arm System sense electrical activity caused by muscle contractions close to the location of the prosthesis attachment. The EMG electrodes then transmit electrical signals to a computer processor in the prosthesis, where they are translated into a specific movement or movements. The device can convert electrical signals for up to 10 powered movements and is the same shape and weight as an adult arm.
The FDA marketing approval is based on a 4-site Department of Veterans Affairs study assessing the DEKA Arm System in 36 participants with limb loss. Approximately 90% of the participants were able to perform activities of common household and self-care tasks using the DEKA Arm System that they were previously unable to perform with their current prosthesis. These tasks included using keys and locks, preparing food, feeding oneself, using zippers, and brushing and combing hair. The review by the FDA was via the de novo premarket review pathway for generally low- to moderate-risk medical devices that are first-of-a-kind.
Funding for the DEKA Arm System was sponsored by the Defense Advanced Research Projects Agency and the U.S. Army Research Office.
For more information visit FDA.gov.