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The Next Stage of Evolution for iRhythm’s Zio Patch

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The San Francisco, CA-based company has won FDA clearance for a new design and upgraded artificial intelligence for the wearable cardiac monitor.

iRhythm Technologies’ wearable cardiac monitor is evolving with the help of two new FDA clearances. The San Francisco, CA-based company’s Zio Patch is now boasting an improved design and updated artificial intelligence.

The new design for the patch, which looks like a bandage, 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. 

Zio Patch is a wearable technology to monitor heart rate activity. It can be argued that the device is on the path of eventually replacing the Holter Monitor, a bulkier battery-operated portable device that measures and records a person’s heart activity continuously for 24 to 48 hours or longer.  

Mark Day, iRhythm's executive vice president of research and design, spoke to MD+DI about the recent clearances saying that is constantly thinking about what it can do to improve the most current generation.

“We started this project about three years ago with the patient in mind – [looking at] how can you improve the patient experience,” Day told MD+DI. “When you’re sticking adhesives to chests and you’re going through summer temperatures that are increasing it comes down to the reality that it’s a tricky problem. If we can get more patients to a better more reliable patient design, then we’ll meet our outcomes more successfully. That was really the impetus for it.”

He added, “our approach to [Zio’s new design] was to look at miniaturization to address both factors – and this about leveraging all of the advantages of Moors Law and circuitry and miniaturization that have come out over time … as well as pushing our team to be bold for a new design. How can we miniaturize this down to the barest possible level being very thoughtful about the interaction between electrical and mechanical dimensions – to make sure that we can create something that is highly useable, highly comfortable, and highly-patient compliant in a unified product.”

Day commented about the firm’s newly cleared AI component. The upgraded AI allows for expanded training of the algorithm across a larger database, resulting in enhanced 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.

“This is purely similar in the theme of continuous improvement, where we are looking at the algorithm we have right now and seeing opportunities for improvement,” Day said. “We’re also watching what’s going on with AI in the entire field of AI work.  We’re also continuing to develop a larger and larger database currently measuring over 750 million hours of curated ECG information. With that tremendous asset of data, comes the ability to pull out more cases – to retrain the algorithm against a broader set of scenarios and to leverage these new technologies and techniques to create a better algorithm.”

iRhythm is one of the first companies to find its groove at the intersection of artificial intelligence and cardiology. The digital health company first won a nod from FDA for the Zio Patch in 2011. In September of 2020, MD+DI named the patch as one of 10 FDA Cleared or Approved Wearable Devices that Redefined Healthcare.

There is great potential for the company’s AI capabilities to expand.

“It’s about leveraging insights from the data that weren’t previously understood,” Day said. “And in the future, it’s about moving from a retrospective analysis, which the clearances we just received are anchored in, [to] using the power of AI to move more toward the power of prediction.”

 

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