FCC Seeks Comment on Bluewind Waiver Request for Medical Device
The FCC Office of Engineering and Technology is seeking comment on a request by Bluewind Medical for a waiver to permit its implantable medical device system operating at 6.78 MHz to exceed FCC emission limits. The company “states its tibial…
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neuromodulation system is intended to be used to treat patients diagnosed with overactive bladder (OAB) and related symptoms,” OET said Thursday: “The implant uses electrical pulses to stimulate nerves innervating the bladder, urinary sphincter, and pelvic floor. The implant receives power and data … through near-field inductive coupling via pulse modulation of a 6.78 MHz carrier signal, at a rate of up to 30 Hz.” BlueWind is seeking a waiver to permit its system to be certified and marketed with external control unit emissions not to exceed 108.8 microvolts per meter field strength, which is above the 100 microvolts limit. Comments are due Feb. 21, replies March 8, in docket 23-27.