InfoBionic, a company out of Lowell, Massachusetts, was awarded 510(k) clearance by the FDA to introduce its MoMe Kardia wireless cardiac monitor in the U.S. The device can work either like an old fashioned Holter monitor or as a mobile cardiac telemetry system. It can be switched between the three modes remotely by a physician, depending on the type of monitoring that’s expected to provide the best results.
The MoMe Kardia is a single device that both records the ECG and accelerometry data and sends it back to the InfoBionic’s cloud storage via a built-in cellular phone transmitter. From there the patient’s physician can analyze the charts and readings in detail. It doesn’t require any Bluetooth or WiFi setup and can be simply programmed, placed on a patient with a few accompanying instructions, and set off to do its electrocardiography. Unusual cardiac events are automatically recorded and there’s also a button the patient can press if he or she suspects an arrhythmia.
The company plans on releasing the MoMe Kardia to the U.S. market within the next few months.
Product page: MoMe Kardia…