According to reports, InfoBionic's remote patient monitoring system, MoMe Kardia, has recently received FDA approval.
MoMe Kardia is designed to monitor patients' electrocardiograms, breathing and exercise to diagnose arrhythmias. This lightweight monitoring device can be hung around your neck or worn on your belt. The current generation of products has been licensed by the FDA, but the equipment has not yet been commercialized.
Company CEO Nancy Briefs said that the first generation of devices is three-in-one, the front of the device is very small, you can send data to the phone via Bluetooth, and then the data is sent to the cloud by the phone. A market survey of equipment in New Zealand showed that patients do not want to carry a device like a mobile phone. In accordance with FDA requirements, equipment must be bundled with the phone to ensure continuous monitoring. Patients will not be able to use their own mobile phones because data communication will be interrupted once Facebook or other programs are used.
InfoBionic decided not to commercialize the first generation of devices, they will develop second-generation devices to commercialize them. MoMe will transfer data to the cloud-based platform for data analysis via cellular devices, minimizing false positive rates. The device has three modes - Dynamic, Time, and Mobile ECG Telemetry (MCT). This means that if the doctor thinks that the patient's heart needs a different monitoring mode, remote control can be used to switch between the three modes.
Doctors can access patient data via the web or via an iOS or Android app. The doctor interface can view patient monitoring progress and automatically generate reports based on multiple parameters and data.
In early 2014, InfoBionic's MoMe system was licensed by CE. A year later the company began applying for an FDA license.
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