Medtronic receives FDA clearance for cardiac monitors

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The FDA has cleared Medtronic’s Reveal DX and Reveal XT, the insertable cardiac monitors (ICMs) that offer unique diagnostic and monitoring insights to cardiologists managing its patients with syncope (fainting) or abnormal heart rhythms, including ventricular tachyarrhythmias (VT), fast ventricular tachyarrhythmias (FVT), bradyarrhythmias and asystole.

Medtronic said its new Reveal DX monitors the heart’s electrical activity in order to help physicians diagnose whether or not symptoms such as fainting, dizziness and unexplained seizure-like episodes have a cardiovascular cause. The company said that placed just under the skin of the chest area using local anesthesia during an outpatient procedure, the Reveal DX monitor records cardiac rhythm data that may help a physician to diagnose the patient so the appropriate treatment can be undertaken.

The new Reveal DX will be commercially available in the United States beginning late December and the Reveal XT will follow, the Minneapolis-based Medtronic said.