iRhythm Technologies, Inc. announced two new 510K clearances – one for a new and improved design of its monitor and a second for updated artificial intelligence (AI) capabilities. The new Zio monitor is designed to significantly improve patient comfort while the advancements to its AI capabilities will further improve rhythm and beat diagnostic accuracy. The clearances demonstrate the company’s ongoing commitment to improving the patient and provider experience – by investing in next-generation capabilities across its diagnostic platform. The new Zio monitor: The new Zio monitor is designed to be effortless to wear with increased adherence and better patient comfort. It’s small enough for patients to forget they are wearing it through exercise, showering, and sleeping. The new design is more than 50% lighter than the current generation and includes a new breathable and waterproof outer layer. It also has an improved ‘stay-put’ adhesive and a more flexible design for a secure attachment. These refinements will allow for a more comfortable wear and, therefore, more complete, accurate diagnostic data. Enhanced AI: iRhythm has made significant system improvements to its deep-learned AI algorithm. The company has collected over 750 million hours of curated heartbeat data, creating the largest repository of labelled ECG patient data in the world. This allows for expanded training of the algorithm across a larger database, resulting in enhanced AI diagnostic accuracy and better quality assurance. On top of the record expansion, iRhythm now has a much more technologically advanced AI backbone – moving from machine-learned to deep-learned capabilities. With AI, the average rhythm detection sensitivity of iRhythm’s detection algorithm has improved by 21% since its creation in 2010. iRhythm has led the cardiac monitoring industry in using FDA-cleared, deep-learned algorithms for classifying and characterizing diverse heart rhythms. iRhythm is now using AI to detect beats, beat types and heart rates – on top of the deep-learned rhythm detection capability introduced and clinically validated in 2019. This allows for AI-based detection of heart activity at a much more granular level, with an enhanced level of accuracy. The updated AI capabilities will be introduced later this quarter for the US-based Zio Service, while the new Zio monitor platform will begin limited release later this year.