Startup gains FDA nod for wearable EKG cardiac arrhythmia monitor

MoMe Kardia--Courtesy of InfoBionic

The FDA has cleared the MoMe Kardia electrocardiogram device from startup InfoBionic to diagnose cardiac arrhythmias. It's a big step up from traditional cardiac monitors and includes three different monitoring types that typically require discrete devices.

But, it's not nearly as convenient as a more consumer-oriented monitoring technology from AliveCor, which comes as a smartphone or tablet attachment and app combo and is FDA-cleared specifically for the diagnosis of atrial fibrillation. This is a common cause of cardiac arrhythmia and a major cause of stroke. AliveCor just announced an upcoming Apple Watch band version of its device--and, coincidentally, put both under a brand umbrella identical to that used by InfoBionic--Kardia.

InfoBionic expects to launch its MoMe Kardia next quarter for ambulatory detection and monitoring. Unlike AliveCor, it will be targeting healthcare providers that are likely still offering patient monitoring via discrete Holter, event or mobile cardiac telemetry (MCT) devices.

"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 InfoBionic co-founder, President and CEO Nancy Briefs in a statement. "MoMe Kardia is a 3-in-1 device that seamlessly transitions between Holter, Event and MCT modes remotely, streamlining patient monitoring time without delays."

She continued, "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. 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 a lightweight worn sensor device; it incorporates a cellular module that transmits data the cloud-based MoMe Software System where algorithms are employed to flag events for physician review. The monitoring is continuous and doesn't require any patient participation to trigger it.

The Lowell, MA-based company has raised roughly $35 million, almost all of it as equity, according to its SEC filings. Its investors include Safeguard Scientifics, Excel Venture Management, Zaffre Investments, which is a subsidiary of Blue Cross Blue Shield of Massachusetts, and undisclosed angel investors.

- here is the announcement