Dean Kamen’s DEKA Arm System, also dubbed the “Luke Arm,” just received FDA approval through the de novo classification process. We first reported on the arm in 2007. Over the past few years the Luke Arm team had to demonstrate the safety of the software and electrical systems, perform durability and impact testing, and implement safeguards for unintentional movements.
Clinical testing included a 4-site Department of Veterans Affairs study involving 36 participants. 90 percent of the participants were able to perform activities with the Luke Arm that they were not able to perform with their current prosthesis, including using keys, preparing food, eating, using zippers, and hair care. The device interfaces with the body through EMG electrodes attached to the feet or near the amputation site and is able to perform 10 powered movements. It is the same weight as an average adult arm. We look forward to hearing more about the device as it hopefully becomes more widely available.
Flashbacks: Medgadget‘s previous Luke Arm coverage…
Product page: The DEKA Luke Arm…
Press release: FDA allows marketing of first prosthetic arm that translates signals from person’s muscles to perform complex tasks