FDA Approves Marketing for DARPA-Developed Prosthetic Arm

FDA will allow marketing of the DEKA Arm System, the first prosthetic arm that can perform multiple, simultaneous powered movements controlled by electrical signals from the muscles.

Nicknamed “Luke” (after Luke Skywalker) the DEKA Arm uses electromyogram (EMG) electrodes to detect muscle contractions and covert the electrical signals into specific movements. The prothetic is designed for people with shoulder joint, mid-upper arm, or mid-lower arm amputations and is the same size and weighs as much as a human arm.
“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,” Christy Foreman, director of the Office of Device Evaluation at CDRH said in a press statement.
Luke was reviewed via FDA's de novo classification process. Among the clinical data reviewed by FDA was a four-site study through the Department of Veterans Affairs in which 36 participants provided data on how the DEKA Arm Performed in common household and self-care tasks. Results showed that 90% of study participants were able to perform a number of activities -including using keys and locks, cooking, feeding themselves, using zippers, and brushing and combing hair -that they were unable to perform with their current prostheses.
DEKA Research and Development, the makers of the arm, was founded by renowned researcher/inventor Dean Kamen and funded through DARPA's prosthetics program to enhance the quality of life for soldiers with upper extremity amputations. Representatives from DEKA were not immediately available for comment.
Watch a video from the Department of Veterans Affairs to see the DEKA Arm System in action.

Learn about "Designing Next-Gen Medical Devices" at the MD&M East Conference June 9, 2014.

-Chris Wiltz, Associate Editor, MD+DI

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