The FCC Office of Engineering and Technology approved a request...
The FCC Office of Engineering and Technology approved a request by Boston Scientific for an extended waiver of FCC rules allowing the company to continuing using the 90-110 kHz frequency band for its Cognis cardiac device as it completes a…
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clinical trial. A trial got under way in 2010, but the current waiver was set to expire Nov. 17, said the order, which was handed down last month but posted by OET Wednesday. The order extends the waiver through Dec. 31, 2013. “This further extension is needed due to unanticipated delays enrolling a sufficient number of patients for a valid clinical trial,” the order states (http://xrl.us/bn3wxo). “According to Boston Scientific, [Food and Drug Administration] protocol requires that the Cognis devices be implanted before patients are assessed for and permission is requested for participation in the trial. In light of the health benefits provided by this device and the value of a successfully executed trial in enhancing patient care, and because the risk of harmful interference to other authorized operations in the band is extremely small, we conclude that good cause exists, and the public interest would be served by, extending the existing waiver."