Medtronic (NYSE:MDT) landed both CE Mark approval in Europe and FDA 510(k) clearance in the U.S. for its Reveal LINQ insertable cardiac monitor.
The Reveal monitor uses the Carelink network to allow physicians to monitor patients from afar. The device is "80% smaller than other ICMs" with a profile about one-third the size of an AAA battery, Medtronic said.
The device is placed right beneath the skin on the upper left side of the chest, indicated for monitoring patients experiencing “dizziness, palpitation, syncope (fainting) and chest pain that may suggest a cardiac arrhythmia, and for patients at increased risk for cardiac arrhythmias,” according to a press release.
“This miniaturized monitoring system is the result of many years of product development work from engineers focused on shrinking the size of medical devices while maintaining their power and improving benefits for patients,” cardiac rhythm management president and Senior VP Pat Mackin said in prepared remarks. “This is game-changing technology for patients who need cardiac monitoring, and we look forward to providing them with the most technologically advanced and minimally invasive approach possible.”