Remote patient monitoring platform iRhythm Technologies has received FDA 501(k) clearance for its ZEUS (Zio ECG Utilization Software) System, a platform and connected sensor-based wearable for a continuous monitoring device used to identify and track irregularities in heart rhythms known as atrial fibrillation (AFib). The 501(k) clearance granted is for the algorithm that provides clinicians with context of how much AFibpatients experience over time.  

The company has received several FDA clearances for its ZEUS System, including a 510(k) clearance obtained in 2021. iRhythm Technologies states that this clearance expands its range of medical algorithms cleared by the FDA. The ZEUS System is currently not available commercially; however, the company is planning a limited launch in 2023. 

California-based iRhythm Technologies is a publicly traded digital healthcare company that produces cardiac monitoring devices. The company’s primary service, ZEUS, entails sending a single-use monitoring device to patients, collecting cardiac-related readings on the device and via an app, retrieving the device and results from patients, and sending the analyzed results to physicians. The company has signed partnerships with companies such as Verily, a subsidiary of Alphabet life science, to enable connectivity with ZEUS and other complementary technology.