Digital health startup InfoBionic said today it won FDA 510(k) clearance for its MoMe Kardia wireless cardiac remote monitoring system designed to aid in the diagnosis of cardiac arrhythmias.
The next-generation MoMe Kardia is a 3-in-1 single piece device that acquires and stores ECG and motion data and transmits them through the company’s cloud-based MoMe Software system for analysis, the Lowell, Mass.-based company said.
“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. 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 analytics directly to the physicians. The sleek, lightweight form factor of MoMe Kardia is designed so patients can wear it discretely 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,” CEO Nancy Briefs said in prepared remarks.
The company said data collected from the system is analyzed by proprietary algorithms, which identify data and flag it for physician review if necessary. The system requires no patient intervention to capture or analyze the data, but does inform the patient of the event trigger.
InfoBionic said it plans to begin shipping the next-gen MoMe Kardia in the 2nd quarter of 2016.