IRTC - iRhythm Technologies wins two FDA clearances

iRhythm Technologies (IRTC) has received FDA’s 510K clearances for a new design of its flagship Zio monitor and its updated artificial intelligence ((AI)) capabilities.“iRhythm’s new Zio monitor and enhanced AI further illustrate our commitment to raising the standard of cardiac care for the providers and patients we serve,” commented Mike Coyle, CEO of iRhythm.Designed to make the device 50% lighter than the current generation, the new Zio monitor has a “breathable and waterproof outer layer,” the company said adding that it is on track for a limited release later this year.This new AI algorithm which is set to be unveiled for the US-based Zio Service in late Q2 2021, “will enable the Zio Service to be even more accurate and scalable, delivering more clinical insight for cardiologists and payers,” noted Mark Day, iRhythm’s executive vice president of R&D.In April, iRhythm fell sharply after Novitas published lower Medicare reimbursements rates for its ECG monitoring

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iRhythm Technologies wins two FDA clearances