FCC Asked to Modify UWB Waiver for Heart Failure Device

Zoll Medical Israel Ltd. has asked the FCC’s Office of Engineering and Technology to modify a part 15 ultra-wideband waiver granted predecessor company Kyma Medical Technologies Ltd. in 2016 that enabled certification and marketing of a medical imaging and diagnostic device, the uCor 3.0 (uCor), which is designed to monitor congestive heart failure patients (TR Daily, Sept. 6, 2016).

In the redacted version of its waiver modification request, which was filed Dec. 26, Zoll noted that last September, it “received an experimental license from the Commission to conduct clinical trials using the modified device. Those trials are proving very successful, and Zoll now desires to commercialize the modified uCor for use by these patients. Because the modification, albeit minor in terms of its spectrum impact, does not meet the strict waiver conditions, Zoll hereby requests the Chief of the Office of Engineering and Technology (‘OET’) grant this Petition under its general delegation of authority. To speed up the process, Zoll further requests that the Petition not be put on public notice so that it and the Commission will be spared the unnecessary and repetitious industry objections that accompany all such UWB waiver requests.”

Zoll said it “has tested the modified device in accordance with the Commission’s rules and measurement procedures (per the waiver) and can confirm that it complies fully with Part 15 Subpart F requirements and shows identical test results to the original uCor device. Thus, there would appear to be no public interest served in soliciting comments on the duty cycle modification requested in this Petition.” —Paul Kirby, paul.kirby@wolterskluwer.com

Courtesy TRDaily