FDA approves MoMe Kardia remote monitor to diagnose cardiac arrhythmias- InfoBionics

The FDA has approved the MoMe Kardia, a wireless, remote monitoring system from InfoBionics which is designed to aid physicians in their diagnosis of cardiac arrhythmias in patients with a demonstrated need for cardiac monitoring.

Competitive wireless ambulatory electrocardiogram ("ECG") monitoring systems are two-unit devices comprising a sensor unit and a handheld unit. Traditionally, the sensor communicates the acquired ECG data to the handheld unit using Bluetooth technology, and the handheld unit then analyzes the ECG data and transmits information to the monitoring center through a cellular modem. The new generation MoMe Kardia is fundamentally different from these traditional systems. It 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 expects to begin shipping the new generation MoMe Kardia in Q2 2016.