iRhythm Technologies
(Nasdaq: IRTC)
announced today that it received CE mark for its Zio system and its supporting Zeus AI algorithm.
San Francisco-based iRhythm designed the next-generation Zio long-term ambulatory cardiac monitor to detect potential cardiac arrhythmias. Zeus, the company’s advanced, deep-learned AI algorithm, supports the capture and analysis of ECG data recorded by Zio. The company secured CE mark based on compliance to EU medical device regulation (MDR) standards.
Zio builds on the previous-generation Zio XT with long-term, continuous cardiac monitoring. It provides an end-to-end experience for patients with potential arrhythmias and demonstrates 99% patient compliance. iRhythm launched the next-generation monitor in the U.S. in September and expects widespread availability this year.
As the company’s smallest, lightest and thinnest cardiac monitor, Zio aims to enhance the cardiac monitoring experience for patients. The company said its new service enhancements also benefit healthcare providers.
iRhythm President and CEO Quentin Blackford called EU MDR “one of the most stringent regulatory frameworks” globally. He said it ensures that devices meet the rigorous standards for healthcare technologies. Receiving CE mark reflects the company’s commitment to deliver the highest quality services, he added.
“Our teams did an excellent job to effectively convey the significant body of clinical study evidence underlying our Zio services and our deep-learned AI algorithm as key differentiators,” Blackford said. “With improved clinical accuracy compared to existing traditional Holter monitoring, we look forward to introducing our innovative technology to many more patients in Europe.”