FDA grants 510(k) clearance for InfoBionic MoMe Kardia

InfoBionics MoMe Kardia system
InfoBionics MoMe Kardia system

InfoBionic has received 510(k) clearance from the US Food and Drug Administration (FDA) for MoMe Kardia, a wireless, remote monitoring system designed to aid the diagnosis of cardiac arrhythmias in patients with a demonstrated need for cardiac monitoring.

Nancy Briefs, president, chief executive officer and co-founder of InfoBionic, says, “MoMe Kardia is a three-in-one device that transitions between Holter, Event and MCT modes remotely. In addition, MoMe Kardia leverages a cloud-based proprietary platform-the first and only of its kind-to deliver on-demand, actionable data and analytics directly to the physicians.”

(Visited 119 times, 1 visits today)