May 12, 2014
DEKA Robotic Arm System Receives FDA Approval
Peter Suciu for redOrbit.com - Your Universe Online
The United States Food and Drug Administration (FDA) has announced that it has given approval for a new robotic arm that is controlled by electrical signals from electromyogram (EMG) electrodes. The DEKA Arm System, which is reportedly the first prosthetic limb that can perform multiple, simultaneous powered movements controlled via EMG signals, had an eight year development cycle from idea to market.
The arm was developed as a part of DARPA's Revolution Prosthetics program, which began in 2006. The developers had found that upper-limb prosthetic technology actually lagged behind lower-limb technology and a goal of the project was to address this gap. Advancing upper-limb technology was also judged to be far more difficult both medically and from an engineering standpoint.
Now, just eight years after the development of the concept, the FDA has approved the DEKA Arm System, which was developed in part by DEKA Integrated Solutions of Manchester, NH.
DARPA invested some $40 million into this project according to Bloomberg Businessweek reporter Alex Wayne. While it won't actually be available for sale just yet, DEKA owns the patents and commercial rights for device.
Without DARPA, however, the DEKA Arm System might have been out of arm's reach for the company.
"Without that kind of money it would be difficult to attract the kind of people I think that we need to solve the problem we’re trying to solve," Matt Albuquerque, president of Next Step Bionics & Prosthetics Inc., which helped DEKA's development process, told Bloomberg Businessweek.
"DARPA is a place where we can bring dreams to life," said Dr. Geoffrey Ling, M.D., director of DARPA's Biological Technologies Office, in a statement.
Dr. Ling is a retired Medical Corps neuro-critical care officer and has served in combat hospitals in both Iraq and Afghanistan. He launched the Revolutionizing Prosthetics program in 2006 to help provide better care “to repay some of the debt we owe to our Service members,” he added.
DARPA noted that this new approved system greatly expands prosthetic choices for amputees, who for decades have had to rely on body-powered prosthetics including the split-hook device that was first invented in 1912.
The DEKA Arm System is different in that it allows for simultaneous control of multiple joints and it utilizes a variety of input devices including wireless signals generated by innovative sensors on the user's feet. The arm system, which offers six user-selectable grips, is battery-powered yet is the size and weight of a natural limb. It can be configured for people with limb loss occurring at the shoulder joint, mid-upper arm or mid-lower arm - however it cannot be configured for limb loss at the elbow or wrist joint.
"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, via 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."
The development of the artificial limb was possible thanks to technology breakthroughs at the intersection of biology and engineering, and includes the greater ability to miniaturize parts for motors, computer controls and sensors; along with the ability to create lightweight but strong and rugged materials.
The FDA had reviewed the clinical information relating to the test, and this included the testing of software and electrical and battery systems, as well as mitigations to prevent or stop unintended movements of the arm and hand mechanisms. The FDA also tested the durability of the device including its ability to withstand exposure to environmental factors including dust and light rain as well as mild impacts.
The FDA also reviewed the 4-site Veterans Affairs study in which 36 DEKA Arm System study participants provided data on how the arm performed in common household and self-care tasks; and the study found that approximately 90 percent of study participants were able to perform activities with the system that they could not perform with current prosthesis. This includes using keys and locks, preparing food and using zippers.
While the arm is science at work, even its developers admit that science fiction had proven an inspiration. On the DEKA Arm official Website the company noted, "affectionately dubbed 'Luke' (after Luke Skywalker), the robotic arm is a DARPA funded project intended to restore functionality for individuals with upper extremity amputations."