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.
Deka calls it "Luke", after Luke Skywalker of "Star Wars" fame, and the project was funded by DARPA.
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.
Credit: Deka Research
“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.”
The FDA reviewed clinical information relating to the device, including a 4-site Department of 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. The study found that approximately 90 percent 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 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.
The DEKA Arm System is manufactured by DEKA Integrated Solutions in Manchester, N.H.
- PHYSICAL SCIENCES
- EARTH SCIENCES
- LIFE SCIENCES
- SOCIAL SCIENCES
Subscribe to the newsletter
Stay in touch with the scientific world!
Know Science And Want To Write?
- Researchers Created A Laser Bullet To See What It Would Look Like - And Here It Is
- What Americans Fear Most Isn't Ebola Or Terrorism, It's...
- Great Earthquakes Doubled In The Most Recent 10 Year Period - What That Means
- ECFA Workshop: Planning For The High Luminosity LHC
- Slavery In America: Back In The Headlines
- Dams Are Not The Smart Way To Secure Water For Agriculture
- Why Climate 'Uncertainty' Is No Excuse For Doing Nothing
- "Very interesting article. There is a fascinating new drug, PSCK9 inhibiter, currently under..."
- "Here is what surface station really have measured..."
- "You enjoy taking down comments you do not like, don't you king of strawman arguments? ..."
- "I'm sorry the definition was 'one who believes there is no diety' Though my point remains valid..."
- "Wasn't the Webster definition 'someone who believes there is no god' Wouldn't this only be applicable..."
- National Wildlife Refuge System bans on GMOs and neonics lack transparency, scientific rationale
- Want better sperm? Eat more pesticides
- Beyond universal donors, some people are programed with no blood type at all
- Anti-conventional ag movement spurs Big Ag to look to organic pesticides
- Can people really inherit memories?
- An end to fat shaming? The 50 year DNA mystery of metabolic dysfunction may soon be solved
- 100 days in Michigan: U-M team releases new analysis of state's Medicaid expansion
- Trans fats still weighing Americans down
- Can bariatric surgery lead to severe headache?
- Study examines readmission after colorectal cancer surgery as quality measure
- Online dermatologic follow-up for atopic dermatitis earns equivalent results