The US Food and Drug Administration (FDA) has issued a warning letter to iRhythm Technologies, Inc. a heart monitoring medical device.
The letter highlights concerns around how the company marketed its product and the labelling of the use of the device.
It stated the product’s use “is intended to continuously record and report patient symptomatic and asymptomatic cardiac events and continuous electrocardiogram information.”
The report continues to add: “It is indicated for use on patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, syncope, fatigue, or anxiety” and that “after wear, a final report of the entire ECG recording is generated.”
It goes on to include that the “reports are provided for review by the intended user to render a diagnosis based on clinical judgment and experience. It is not intended for use on critical care patients.”
Upon investigation into the marketing materials and documents used to describe the device, the FDA highlights the marketing descriptions used included: “that the Zio AT Patch System is intended for “near real-time monitoring” as a “mobile cardiac telemetry monitor,” can provide notifications “immediately,” and that it is intended for “high-risk patients”.” Therefore the FDA notes that “the claim that the device is intended as a mobile cardiac telemetry monitor implies this device is intended for high-risk patients and near real-time monitoring and that the firm describes a new patient population, instead of non-critical care.”
The FDA goes on to add that “describing a new patient population could significantly affect the safety and effectiveness” and “high risk patients need near real-time monitoring because they are more likely to have a life-threatening arrhythmia. Accordingly, these changes required the submission of a new 510(k).”
To view the letter, please click here.
