Digital health specialists gain 2 new FDA clearances for cardiac care portfolio
iRhythm Technologies, a San Francisco-based digital health company focused on diagnosing cardiac arrhythmias, has gained two new FDA clearances—one for its new-look Zio monitor and another for its advanced AI algorithm.
The Zio monitor, one of iRhythm’s flagship offerings, has been updated to be more lightweight and comfortable than in the past. The improvements, the company said, should help providers capture more accurate data and paint more complete picture of the patient’s health.
“iRhythm started with the patient in mind first,” Judy Lenane, RN, iRhythm’s chief clinical officer and executive vice president of products, said in a prepared statement. “We asked ourselves what it would take to give patients the best, most comfortable experience, and designed it from there.”
The company’s newly approved AI algorithm, on the other hand, was trained using data from more than 750 hours of curated electrocardiogram data and features a “much more technologically advanced AI backbone.” All told, iRhythm said, the algorithm’s sensitivity has improved by 21% since it was first developed back in 2010
“iRhythm’s new Zio monitor and enhanced AI further illustrates our commitment to raising the standard of cardiac care for the providers and patients we serve,” Mike Coyle, CEO of iRhythm, said in the same statement. “By improving patient comfort and experience we can continue to maximize patient compliance, which is an essential element for collecting high-quality data for analysis. And with the power of our next generation AI, we can help physicians better identify, diagnose and manage a wide array of significant arrhythmias, including atrial fibrillation.”
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.