Startup Infobionics Clears FDA Approval of New Generation MoMe Kardia for Cardiac Arrhythmias Diagnosis


Startup InfoBionic Inc. (USA) announced that it received clearance from the US Food And Drug Administration (FDA) for its MoMe Kardia, the first and only wireless remote controlled system designed for the diagnosis of Cardiac Arrhythmias.

The traditional competitive ambulatory electrocardiogram (ECG) monitoring systems comprise of two units; one sensor unit and one handheld unit. The sensor acquires the ECG data and communicates the same to the handheld unit using Bluetooth technology. The handheld unit then analyses the ECG data and transmits this data to the monitoring centre system through a cellular modem.

On the contrary, the new generation MoMe Kardia in the first of its kind 3- in -1 single piece device that acquires and stores ECG and motion data and transmits that data through embedded cellular technology to the MoMe software system. The MoMe software system is a cloud based platform. The transmitted data is then analysed by the MoMe software and the data thus identified is flagged for review by the physician.

We’re thrilled to announce FDA 510(k) clearance to market for MoMe Kardia, which supports our mission to create superior patient monitoring solutions for arrhythmia detection and chronic disease management,” said Nancy Briefs, President, CEO and Co-Founder of InfoBionic. “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 analytic directly to the physicians. The sleek, lightweight form factor of MoMe Kardia is designed so patients can wear it discreetly and manage only one device during monitoring. MoMe Kardia empowers physicians to transform the efficiency with which they manage cardiac arrhythmia detection and monitoring processes for their patients.”

The MoMe Kardia is not as convenient as is a more consumer friendly market player in the field by Alivecor. The monitoring system from Alivecor comes as a smartphone attachment and app combo and is already FDA approved for the diagnosis of cardiac arrhythmia. In the meanwhile, Alivecor has just announced an upcoming Apple Watch band version of its device.

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

Watch 90-Second InfoBionic MoMe video explaining how it works (Courtesy: InfoBionic Inc.)

Featured image credit: Color-Cardiovascular-Monitor © fmua (Stock Photo ID: 6847919)

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