InfoBionic receives FDA clearance for cellular-enabled heart monitoring device

By Aditi Pai
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Lowell, Massachusetts-based InfoBionic has received FDA 510(k) clearance for its remote patient monitoring system, MoMe Kardia, not to be confused with AliveCor’s recently product portfolio rebrand, which is also now named Kardia.

The MoMe Kardia is designed to help detect cardiac arrhythmias in patients by sensing ECG, respiration, and motion. The lightweight monitoring device can be worn as a necklace or belt attachment. A first generation of MoMe Cardia already received FDA clearance, but this version was never commercialized.

“The first generation device was a 3-in-1, like this,” InfoBionic CEO Nancy Briefs told MobiHealthNews. “It had a very small front end that collected the data but then would Bluetooth that data to a cell phone that would then send from the cell phone to the cloud. When we ran a marketing trial in New Zealand on the device, the patient feedback was they didn’t like carrying a second cell phone. Because it’s continuously sending information, we had to provide a locked down phone, according to the FDA, that the patient would carry. You couldn’t use your own phone because if you wanted to go on LinkedIn or do Facebook or something, you could disrupt that communications.”

InfoBionic decided that instead of commercializing their original device, they would wait for the second generation. MoMe transmits data via cellular to a cloud-based platform where the data is analyzed, which minimizes false positives. The device works as a Holter, Event, and Mobile Cardiac Telemetry (MCT) monitor. This means, if a physician feels that the patient's cardiac symptoms call for a different type of monitoring technology, they can switch the device remotely to any one of three main monitoring modes.

A physician can access the patient’s data via web as well as iOS and Android app. The physician dashboard provides views of patient monitoring progress and generates automated reporting in multiple parameters and data displays.

At the beginning of 2014, InfoBionic received a CE Mark for the MoMe System. Later that year, the company secured FDA clearance for prescription use.

While InfoBionic's device currently has a similar name to AliveCor's Kardia, AliveCor told MobiHealthNews they had already filed for a trademark. Breifs told MobiHealthNews that InfoBionic was told by their legal team that because “Kardia” is the Greek word for “heart”, it would not be able to trademark it. Briefs added, though, that the company has been using Kardia in marketing and on the company’s website for 18 months.