Fierce Biotech January 3, 2024
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...