Medtronic’s new ICM gains FDA clearance, CE mark approval
Medtronic has gained FDA clearance and CE mark approval for its new LINQ II insertable cardiac monitor (ICM).
The device, which is roughly one-third the size of a AAA battery, was designed to last for four and a half years and features clinician-controlled remote programming. It also stands as the only ICM with a built-in premature ventricular contraction detector. Patients have the choice of sending data with their smartphones or a separate home communicator solution.
“In the current COVID-19 environment, the LINQ II system offers patients a seamless way to experience ongoing connectivity between their device and their physician, while reducing the need for in-office visits,” Rob Kowal, MD, PhD, chief medical officer of Medtronic’s Cardiac Rhythm and Heart Failure division, said in a statement. “LINQ II gives physicians actionable data to help diagnose underlying heart conditions and define treatment protocols for patients with atrial fibrillation or other abnormal heart rhythms.”
Medtronic expects the LINQ II to hit the U.S. and European markets in the near future.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.