|The DEKA Arm System--Courtesy of DARPA|
The FDA approved the first robotic arm for amputees that can translate muscle signals into specific, simultaneous movements, a significant advance over the existing prosthesis.
The agency reviewed the DEKA Arm System through its de novo classification process, a regulatory pathway that allows innovative, low- to moderate-risk devices to receive accelerated clearance. Developed by New Hampshire-based DEKA Research and Development Corp, the DEKA system uses electromyogram (EMG) electrodes to detect electrical activity caused by the contraction of muscles close to where the prosthetic limb is attached. Electrodes can convert electrical signals into 10 powered movements, and the prosthesis mimics the size and shape of an adult arm, the FDA said in a statement.
The FDA based its approval on a four-site Department of Veterans Affairs study, in which 36 participants provided data on how the arm performed in common tasks. The study found that approximately 90% of participants could perform activities with the DEKA system that they were not able to complete before, such as using keys and locks, preparing food and using zippers.
"This innovative prosthesis provides a new option for people with certain kinds of arm amputations," Christy Foreman, director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health, said 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."
While the prosthesis is now approved for marketing in the U.S., it could be particularly beneficial to veterans. The Pentagon's Defense Advanced Research Projects Agency (DARPA) provided more than $40 million in funding to develop the robotic arm as part of a $100 million project to improve prosthetics, Reuters reports. The Pentagon latched onto the idea after assessing injuries sustained by U.S. troops in the Iraq and Afghanistan Wars. More than 1,800 U.S. service members underwent major limb amputations as a result of those injuries.
The only technology available before the current prosthesis was a metal hook, Justin Sanchez, a program manager in DARPA's biological technologies office, told Reuters. DEKA's robotic arm "was designed to produce near-natural upper extremity control to injured people who have suffered amputations," Sanchez said. "The prosthetic limb system can pick up objects as delicate as a grape, as well be able to handle very rugged tools like a hand drill."
The robotic arm is approved for limb loss occurring at the shoulder joint, mid-upper arm or mid-lower arm, but not at the elbow or wrist joint, the FDA said in a statement.
- read the release
- here's the Reuters story