iRhythm Technologies has secured European approval for its latest Zio wearable cardiac monitor, designed to help catch hidden irregular heartbeats such as atrial fibrillation.
The new model is made to be significantly smaller, thinner and lighter compared to the company’s previous Zio XT ECG-recording patch.
According to iRhythm, cases of arrhythmia and stroke have been on the rise in Europe, demonstrating a need for improved detection. The CE mark’s green light covers both the 14-day Zio wearable monitor and its artificial intelligence-powered ECG analysis software, dubbed ZEUS.
“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,” President and CEO Quentin Blackford said in a statement. “With improved clinical accuracy compared to existing traditional Holter monitoring, we look forward to introducing our innovative technology to many more patients in Europe.”
The company said it plans to continue expanding its commercial reach in selected countries on the continent, where about 1.8 million cardiac monitoring tests are performed each year.
The new Zio saw its stateside debut last September. U.S. studies have shown 99% patient compliance, the company said, with participants wearing the device and collecting data across their prescribed duration. The patch does not need to be recharged and features breathable adhesives and a waterproof sensor housing.
In its most recent earnings report last November, iRhythm logged $124.6 million in revenue in the third quarter of 2023, for a 20% gain over the same period the previous year. Operating expenses reached $110.1 million, alongside a total net loss of $27.1 million for the quarter.
At the time, the company projected about 19% sales growth for the full year, with total revenues landing between $487.5 million and $490 million. iRhythm is scheduled to present at the J.P. Morgan Healthcare Conference in San Francisco next week, on Jan. 8.