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FDA APPROVES HUMAN BRAIN IMPLANT DEVICES (STA BREAKING NEWS and ARCHIVES)

by Theresa, Tuesday, April 13, 2004, 23:33




Maryam Saleh, a Cyberkinetics Inc. clinical research assistant, holds a brain gate censor, which will be implanted beneath the skull, at the company in Foxboro, Mass., Tuesday, April 13, 2004. Cyberkinetics of Foxboro has received Food and Drug Administration approval to begin a clinical trial in which four-square-millimeter chips will be implanted beneath the skulls of paralyzed patients. If successful, the chips could allow patients to send computer commands, essentially by thinking about them. (AP Photo/Chitose Suzuki)

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FDA Approves Human Brain Implant Devices

Apr 13, 6:34 PM (ET)

By JUSTIN POPE

AP

BOSTON (AP) - For years, futurists have dreamed of machines that can read minds, then act on instructions as they are thought. Now, human trials are set to begin on a brain-computer interface involving implants.

Cyberkinetics Inc. of Foxboro, Mass., has received Food and Drug Administration approval to begin a clinical trial in which four-square-millimeter chips will be placed beneath the skulls of paralyzed patients.

If successful, the chips could allow patients to command a computer to act - merely by thinking about the instructions they wish to send.

It's a small, early step in a mission to improve the quality of life for victims of strokes and debilitating diseases like cerebral palsy or Lou Gehrig's. Many victims of such ailments can now survive for long periods thanks to life support, but their quality of life is poor.

"A computer is a gateway to everything else these patients would like to do, including motivating your own muscles through electrical stimulation," said Cyberkinetics chief executive Tim Surgenor. "This is a step in the process."

The company is far from the only research group active in the field. An Atlanta company, Neural Signals, has conducted six similar implants as part of a clinical trial and hopes to conduct more. But for now, its device contains relatively simple electrodes, and experts say Cyberkinetics will be the first to engage in a long-term, human trial with a more sophisticated device placed inside a patient's brain. It hopes to bring a product to market in three to five years.

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