Medtronic implantable cardiac monitors
This article was originally published in The Gray Sheet
Executive Summary
Medtronic's Reveal DX next-generation implantable cardiac monitor will debut in the U.S. the week of Dec. 17 following 510(k) clearance Nov. 21, the firm announces Dec. 12. Building on the firm's earlier generation Reveal insertable loop recorders, the advanced Reveal DX has enhanced ECG and trend data capabilities, and can monitor the heart continuously for up to three years instead of just 14 months with the old system, the company explains. Placed just under the skin in the chest area, Reveal DX has no lead wires and helps physicians to diagnose whether symptoms such as dizziness and fainting are caused by cardiovascular problems, the firm says. Medtronic's similar Reveal XT, also cleared by FDA Nov. 21, is marketed in Europe for atrial fibrillation monitoring and is expected to debut in the United States at a later date