FDA allows marketing of first prosthetic arm that translates signals from person’s muscles to perform complex tasks
For Immediate Release: May 9, 2014 Media Inquiries: Susan Laine, 301-796-5349, susan.laine@fda.hhs.gov Consumer Inquiries: 888-INFO-FDA
FDA allows marketing of first prosthetic arm that translates signals from persons muscles to perform complex tasks
The U.S. Food and Drug Administration (FDA) today allowed marketing of the DEKA Arm System, the first prosthetic arm that can perform multiple, simultaneous powered movements controlled by electrical signals from electromyogram (EMG) electrodes.
EMG electrodes detect electrical activity caused by the contraction of muscles close to where the prosthesis is attached. The electrodes send the electrical signals to a computer processor in the prosthesis that translates them to a specific movement or movements.
The EMG electrodes in the DEKA Arm System convert electrical signals into up to 10 powered movements, and it is the same shape and weight as an adult arm.In addition to the EMG electrodes, the DEKA Arm System contains a combination of mechanisms including switches, movement sensors, and force sensors that cause the prosthesis to move.
This innovative prosthesis provides a new option for people with certain kinds of arm amputations, said Christy Foreman, director of the Office of Device Evaluation at the FDAs Center for Devices and Radiological Health. 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 DEKA Arm System can be configured for people with limb loss occurring at the shoulder joint, mid-upper arm, or mid-lower arm.It cannot be configured for limb loss at the elbow or wrist joint.
Data reviewed by the FDA also included testing of software and electrical and battery systems, mitigations to prevent or stop unintended movements of the arm and hand mechanisms, durability testing (such as ability to withstand exposure to common environmental factors such as dust and light rain), and impact testing. The FDA reviewed the DEKA Arm System through its de novo classification process, a regulatory pathway for some novel low- to moderate-risk medical devices that are first-of-a-kind.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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