3-in-1 Cardiac Arrhythmias Remote Monitoring System gets FDA Clearance

InfoBionic, Inc. today announced that it received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) for MoMe^® Kardia, a wireless, remote monitoring system designed to aid physicians in their diagnosis of cardiac arrhythmias in patients with a demonstrated need for cardiac Monitoring.

MoMe^® Kardia is the first 3-in-1 single piece device that acquires and stores ECG and motion data and transmits that data via embedded cellular technology to the MoMe^® Software System, a cloud-based platform with proprietary algorithms for analysis, using the MoMe^® Device Communications Protocol. The transmitted data is then analyzed by the MoMe^® Software Platform via completely new and robust server-based algorithms and when indicated, data identified by these algorithms is flagged for physician review. MoMe^® Kardia requires no patient intervention to capture or analyze data, however it does provide a patient event trigger.

 

 

InfoBionic news release could be found from this link.