FCC Gets Two Views on Heart Failure Device Waiver

The FCC has gotten two views on a waiver request that would allow a company to deploy a device that can measure lung fluid measurements for congestive heart failure patents in a non-invasive way. The FCC’s Office of Engineering and Technology solicited comment last month on the waiver request filed by Sensible Medical Innovations Ltd. (TR Daily, Feb. 9). The waiver would “allow the marketing and operation of its stepped frequency ultra-wideband (UWB) medical imaging and diagnostic equipment known as the ReDs System.” A public notice observed that “Sensible states that the ReDs System can provide accurate lung fluid measurements for congestive heart failure patients in a non-invasive way. The device operates over the frequency range of 1005-1709 MHz.”

In a comment filed in ET docket 18-39, the GPS Innovation Alliance said that it “appreciates and supports advances in medical technologies and the promise that SMI’s ReDS device might bring to treat congestive heart failure. The record currently before the Commission, however, fails to address questions, including how ReDS operations will impact critical GPS services. Those questions should be answered before SMI tis allowed to proceed. The GPSIA therefore respectfully requests that the Commission defer any action on the requested Waiver until SMI provides complete technical and operational information regarding its product, including the information discussed herein, and it otherwise ensures that GPS operations are adequately protected.”

But the National Public Safety Telecommunications Council said it “supports grant of the waivers requested by Sensible Medical Innovations. In offering this support, NPSTC is guided primarily by its view that a non-invasive medical system to measure lung fluid in congestive heart failure patients provides positive benefits to patients, and potentially to emergency medical service (EMS) personnel that may need to serve these patients.”

NPSTC added that “multiple technical factors including the specific frequency range used, a low duty cycle and reliance on spread spectrum technology would contribute to a low risk of interference to public safety communications. Should interference occur despite the apparent relatively low risk, NPSTC believes that Sensible Medical Innovations, Ltd. would need to take steps expeditiously to resolve the problem. Accordingly, NPSTC recommends the Commission determine whether a non-interference condition is needed if the requested waivers are granted.”- Paul Kirby, paul.kirby@wolterskluwer.com

Courtesy TRDaily