May 8, 2014

SILVER SPRING, Md. — The FDA Friday approved marketing of the first powered prosthetic arm that the user can control with his or her thoughts.

Made by New Hampshire-based DEKA Integrated Solutions, the device detects and translates electromyographic activity in nearby muscles — which the user can consciously control — into signals that direct specific movements and actions in the prosthetic arm.

It’s the same size and weight as a normal adult arm and is capable of 10 different powered movements, according to the FDA.

Approval was based primarily on a trial in 36 participants who were patients in the Veterans Affairs medical system.

“The study found that approximately 90% of study participants were able to perform activities with the DEKA Arm System that they were not able to perform with their current prosthesis, such as using keys and locks, preparing food, feeding oneself, using zippers, and brushing and combing hair,” the FDA said.

Other data covered the device’s ability to function in adverse environmental conditions and to survive impacts. The FDA also reviewed safety features to prevent unwanted movements.

“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, in a statement.

“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.”

Configurations are available for a variety of arm amputations, from mid-lower arm to the entire arm at the shoulder joint, the agency said.

The FDA had determined that device failure would not put patients at severe risk, allowing DEKA to apply through the de novo classification process for first-in-class products.


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