WIN! for the Medical Community


FDA expedites review of robotic arm.

by Los Angeles Times:

The lifelike limb, controlled by a chip planted on the brain, is being tested as part of a program designed to speed development of medical devices. 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 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.

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.

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. 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.

Los Angeles Times

A Win! for the medical community indeed.

Although, the Pentagon initially developed this for veterans, robotic limbs could transform humankind. Gone could be the days where humans had to ‘adjust’ to life after losing a limb. And since the Affordable Health Care act passed, all humans regardless of income will be able to live with all limbs intact.

Glad to see Obama keep his word with the American humans on reviewing procedures that may inhibit technological innovation.

Each day that passes, the future looks more and more appealing.