iRhythm Technologies (NSDQ:IRTC) announced that it received FDA 510(k) clearances for to updates to its technologies.
San Francisco-based iRhythm’s first clearance came for a new and improved design of its flagship Zio monitor and the second covered updated artificial intelligence (AI) capabilities, according to a news release.
The new monitor for the Zio ambulatory cardiac monitoring patch for detecting Afib offers increased adherence and better patient comfort, the company said. Its size allows for patients to forget they are wearing it during exercise, showering and sleeping, while the design is 50% lighter than the current generation with a breathable and waterproof outer layer.
Additionally, the monitor includes a “stay-put” adhesive and a flexible design for secure attachment, allowing for a more comfortable wear and more accurate diagnostic data, iRhythm said.
“iRhythm started with the patient in mind first,” iRhythm chief clinical officer & EVP of products Judy Lenane said in the release. “We asked ourselves what it would take to give patients the best, most comfortable experience, and designed it from there. We’re excited to offer more patients around the world access, as well as an improved patient experience, which will enable far more insight into the data.”
The new, enhanced AI capabilities for iRhythm uses more than 750 million hours of curated heartbeat data in a repository of labeled ECG patient data to allow for expanded training of the algorithm to improve diagnostic accuracy and quality assurance.
iRhythm said it now has a more technologically advanced AI backbone that has moved from machine-learned to deep-learned capabilities
“With this clearance, we are excited to be further improving on our AI-based detection capabilities, raising the bar for the cardiac monitoring industry,” iRhythm EVP of R&D Mark Day, said. “This new AI algorithm will enable the Zio Service to be even more accurate and scalable, delivering more clinical insight for cardiologists and payers.”
The company plans to introduce the updated AI capabilities later this quarter, while the new Zio monitor will launch under a limited release later this year.
“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,” iRhythm CEO Mike Coyle said. “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.”