Kyla Gets FCC Waiver for Medical Device
The FCC Office of Engineering and Technology approved a waiver for Kyma Medical Technologies to start selling a medical imaging and diagnostic device. The uCor 3.0 is designed to monitor patients with congestive heart failure but required a waiver for…
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unlicensed ultra-wideband (UWB) devices. The waiver covers rules for definition, measurement procedure, permissible frequency range and coordination, OET said in a Tuesday order. “The device employs a very low power RF signal that is directed into the patient’s torso via a small transmitter that is temporarily attached to the skin,” OET said. “Signals from the uCor propagate through the chest and lungs and reflect back from the heart. Data collected by the uCor is transferred via standard wireless interface over the internet and on to a data center where it can be analyzed by a healthcare provider.” After taking comment on a waiver request, OET said it found that granting the waiver wouldn’t undermine FCC rules. “The uCor device is functionally equivalent to other types of UWB imaging devices contemplated under the rules and that the risk of interference from the uCor device will be no greater than from other such UWB imaging devices,” the order said.