Robotic arm getting a hand from the FDA
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 program seeks to quickly identify and nurture technology that has the potential to transform medical care and the way it is delivered to patients.
The development and review of new drugs and devices typically takes so long and is so expensive that some critics of the process have called it a graveyard for innovation.
“We must turn what has long been considered the valley of death into the pathway to success,” said Jeffrey Shuren, head of the FDA’s office of medical devices.
The silver and black arm can rotate, twist and bend 27 different ways, mimicking the action of a natural limb, said Geoffrey Ling, program manager for the revolutionizing prosthetics program run by the Pentagon’s Defense Advanced Research Projects Agency.
The arm is “truly transformative ... anthropomorphic, just like the arm each of us has,” said Ling, who along with Shuren spoke on a webcast for reporters.
Ultimately, the device may benefit stroke victims, quadriplegics or anyone who has lost the use of an arm, but it’s initially targeted for service members who have lost use of one or both arms in Iraq and Afghanistan.
Advances in body armor and faster medical treatment have enabled more soldiers and Marines to survive serious wounds, which in turn has increased the number of veterans in need of prosthetics.
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.
In some cases the body rejects the chip as a foreign object, and in other cases the signal degrades, he said.
If trials are successful, developers hope the arm will be commercially available in four or five years.
Officials hope the expedited review -- in which an FDA case manager guides the application and engineers have early access to senior agency scientists -- will cut in half the time it takes to approve or reject a device. Devices accepted for speedy review must still meet all safety standards.
Shuren acknowledged, however, that the FDA had limited money for fast-track reviews, and that initially, speedy evaluations would be limited to one or two a year.
He pledged better communication with industry on such issues as when research data compiled outside the U.S. could be used in support of applications.