FDA Allows Marketing of First Prosthetic Arm dubbed “Luke”

4 years ago
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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. This is the first time FDA has allowed marketing of a prosthetic arm.

Functioning of the prosthesis is by determining contraction of muscles close to the prosthesis by  electromyogram (EMG) electrodes in those contracting muscles. Electrodes then convert muscle contraction signal into electrical signals and transmits it to computer processor of the prosthesis which carries out leads to the desired movement. Electrodes in the DEKA Arm System convert electrical signals into up to 10 powered movements. The size of the prosthesis is same as that of an average human arm.

Along with electrodes for signal transmission, DEKA Arm System also has a combination of mechanisms including switches, movement sensors, and force sensors that cause the prosthesis to move.

FDA announcement states:

“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 FDA’s 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.”

FDA analyzed clinical information of prosthesis which was used by 36 participants to be used in common household and self-care tasks. The study found that approximately 90% of the volunteers using DEKA Arm System were able to perform tasks which were not possible with their currently used prosthesis. Tasks which participants were able to perform includes using keys and locks, preparing food, feeding oneself, using zippers, and brushing and combing hair.

DEKA Arm System can be configured for people with limb loss occurring at the shoulder joint, mid-upper arm, or mid-lower arm but It cannot be configured for limb loss at the elbow or wrist joint.

FDA report also states “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 name DEKA is derived from Dean Kamen‘s name who is founder of the company DEKA Research & Development Corporation (1982). DEKA Arm System Affectionately dubbed “Luke” (after Luke Skywalker in Star wars movie series who had similar hand prosthesis) and is manufactured by DEKA Integrated Solutions in Manchester, N.H. This is a DARPA (Defense Advanced Research Projects Agency) funded project. According to Bloomberg report “The Pentagon’s Defense Advanced Research Projects Agency (DARPA) said it provided more than $40 million in funding to DEKA to develop the robotic arm as part of a $100 million project to improve prosthetics.”

 

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