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Articles

FCC Waives Its Rules to Permit Wireless Implantable Medical Technology

November 20, 2009

Articles

FCC Waives Its Rules to Permit Wireless Implantable Medical Technology

November 20, 2009

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The Federal Communications Commission (FCC) waived its technical rules on low-power unlicensed radio devices to permit EnteroMedics to market an implantable medical device to be used for the treatment of gastro-intestinal disorders, such as obesity, diabetes and pancreatitis, by disrupting communications between the vagus nerve and the brain. The implanted device receives both power and communications signals from an external controller that operates at 6.78 MHz and that is connected by a short cable to an external antenna attached to the skin. Although the signal needed to transmit power to the device is within the FCC’s Part 18 limits for Industrial, Scientific and Medical (ISM) equipment, the transmission of communications on that same frequency would exceed the FCC’s Part 15 emission limits for unlicensed communications devices.

The FCC agreed to waive its Part 15 emission limits to permit the marketing of these devices in the United States. The FCC found that the public interest would be served in helping patients manage their obesity, and thereby reduce health care spending, by allowing operation of these devices at power levels that significantly exceed the normal Part 15 limits. The FCC noted that this waiver applies only to these specific implant devices and is not considered to apply generally to other devices, which would have to be separately justified on a similar showing.

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