iRhythm Secures 510(k) Clearance After FDA Warning

iRhythm Technologies has received 510(k) clearance for updates to its Zio AT continuous monitoring system, following a previous FDA warning citing regulatory violations. The Zio AT patch, paired with iRhythm’s AI-powered ZEUS software, monitors heart activity for symptomatic and asymptomatic events. While the FDA identified concerns, including two patient deaths, iRhythm has addressed key issues and awaits a second clearance. With improved compliance, the company’s shares surged by nearly 18%. The Zio AT system continues to provide long-term heart monitoring for patients while expanding its global presence with recent regulatory approval in Japan.