FDA To Accelerate Review of Robot Arm-Hopefully the Funds Will be Available for the Agency-Clinical Trials Require Brain Implant
Posted Feb 09 2011 1:34pm
I think I have covered almost every type of prosthetic arm on this blog in the last couple of years but this is a bit different with a brain implant required to control the device, so something to think about from one angle. On the other side of the coin someone who has lost an arm or even both arms would welcome the opportunity and waling a mile in their shoes is probably the way to go with reasoning and quality of life. Johns Hopkins is involved in the process with their research too so perhaps that might add a little more impact.
It’s wonderful to have all of this technology being developed, but sadly on the budget side of what we hear in the news today, how much of it will we be able to afford and what will insurance cover? There’s a lot of unanswered questions in the future. BD
Responding to the needs of badly wounded war veterans, federal officials said Tuesday they were accelerating reviews of a science-fiction-like robotic arm controlled by a computer chip on the brain . The device would make the use of prosthetic arms, hands and fingers seem almost natural by using a microchip implanted on the brain to record and decode signals to neurons that control the prosthesis. In a dramatic video accompanying the announcement by the Food and Drug Administration, the prosthetic arm wielded pliers and picked up a clothespin to demonstrate its dexterity. The system, developed over the last five years at a cost of more than $100 million by the Pentagon's advanced technology research program, will become the first to be reviewed under a new FDA program designed to make promising medical devices available sooner.
The limb in Tuesday's demonstration was controlled by an engineer. "The next step is planting a chip on the brain," something that will be done to patients within six months in order to begin clinical trials on the device, Ling said. Five patients will initially be implanted with the chips and monitored for a year, said Mike McLoughlin, program manager for the prosthetics project at Johns Hopkins University , a major collaborator on the device. The use of chips to control artificial limbs is established technology, but the performance of the chips over time is an area of concern, McLoughlin said.
Shuren acknowledged, however, that the FDA had limited money for fast-track reviews, and initially speedy evaluations would be limited to one or two a year.