Wearable Cardiac Monitor Earns Two FDA Clearances

The FDA has given iRhythm Technologies two new 510(k) clearances for its Zio heart monitor, one for an improved design of the monitor and the other for updated artificial intelligence (AI) capabilities.

The wearable device is small enough to be worn during exercise, showering and sleeping, and the new version features a more flexible design for secure attachment.

The company’s improvements to the system’s deep-learning AI algorithm were also cleared by the FDA. The algorithm learned from a database of more than 750 million hours of curated heartbeat data, the largest repository of labeled electrocardiogram patient data in the world, iRhythm said.