FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

InfoBionic Scoops Up FDA Clearance

March 17, 2016

InfoBionic has scored FDA clearance for MoMe Kardia, a wireless ambulatory electrocardiogram monitoring system that can send actionable data and analytics directly to the physicians.

The MoMe Kardia can shift between Holter, Event and MCT modes remotely and updates patient monitoring time without delays, the company says.

MoMe Kardia is a 3-in-1 device that receives and harnesses ECG and motion data and delivers it by integrated cellular technology to its cloud-based platform for analysis. Further, the device does not require patient intervention, only an event trigger.

The company plans to launch the product during the second quarter. — Anisa Jibrell