FDA grants 510(k) clearance for InfoBionic MoMe Kardia

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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.”

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