InfoBionic has received 510(k) clearance from the U.S. FDA for MoMe Kardia, a wireless, remote monitoring system that aids physicians in their diagnosis of cardiac arrhythmias in patients with a demonstrated need for cardiac monitoring.

“MoMe Kardia is a 3-in-1 device that seamlessly transitions between Holter, Event and MCT modes remotely, streamlining patient monitoring time without delays,” Nancy Briefs, President, CEO and Co-Founder of InfoBionic, said in a statement. “In addition, MoMe Kardia leverages a comprehensive cloud-based proprietary platform-the first and only of its kind-to deliver on-demand, actionable data and analytics directly to the physicians. The sleek, lightweight form factor of MoMe Kardia is designed so patients can wear it discretely and manage only one device during monitoring.”

MoMe Kardia 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 data is then analyzed by the MoMe Software Platform and when identified by algorithms – flagged for physician review. The device itself requires no patient intervention to capture or analyze data, but it does provide a patient event trigger.

InfoBionic expects to begin shipping the new generation MoMe Kardia in the second quarter of 2016.