Digital health company InfoBionic has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its wireless remote monitoring system, MoMe Kardia.
The new monitoring system will enable physicians to diagnose cardiac arrhythmias in patients with a demonstrated need for cardiac monitoring, the company said.
Competitive wireless ambulatory electrocardiogram (ECG) monitoring systems are two-unit devices, which include a sensor unit and a handheld unit.
Claimed to be the first 3-in-1 single piece device, the MoMe Kardia captures, and stores ECG and motion data.
The data will be transmitted through the embedded cellular technology to the MoMe software system by using the MoMe device communications protocol.
Later, the transmitted data is analyzed by the MoMe software platform through server-based algorithms, and when indicated, data identified by these algorithms is flagged for physician review.
The company said that MoMe Kardia requires no patient intervention to capture or analyze data but it does provide a patient event trigger.
MoMe Kardia is expected to available for the customers in the second quarter of this year.
InfoBionic president, CEO and co-founder Nancy Briefs said: "MoMe Kardia is a 3-in-1 device that seamlessly transitions between Holter, Event and MCT modes remotely, streamlining patient monitoring time without delays.
"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."
Image: InfoBionic’ s MoMe Kardia wireless remote monitoring system. Photo: courtesy of InfoBionic, Inc.