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New Apple Watch is more than your average wearable

09/19/201809/18/2018 Jennifer Goula

New Apple Watch - Apple Watch Series 4 - Apple - YouTube

The Apple Watch Series 4 has been granted FDA Clearance for ECG monitoring. Receiving clearance from the U.S. Food and Drug Administration (FDA), makes the new Apple Watch the first consumer device to receive this clearance from the federal agency to operate as an over-the-counter (OTC) ECG-monitoring device. The Apple Watch Series 4 is one of the only devices on the market to provide users EKG readings. Upon the unveiling of its new Apple Watch, at its September event, the tech giant confirmed that the approval its smartwatch received from…

FDA to fast-tack its review of unique potassium screening mHealth device

09/13/201809/12/2018 Amanda Giasson

mHealth anemia detection app - Needle - Blood - Syringe

AliveCor has designed a device that can detect dangerously high levels of potassium. The US Food and Drug Administration (FDA), has given “Breakthrough Device” status to a potassium screening mHealth device developed by California-based medical device company AliveCor. The company’s KardiaK mHealth platform has been created to analyze ECG readings to detect dangerously high level of potassium in a person’s blood, without the need to draw blood. The digital health tools is designed to detect hyperkalemia. Hyperkalemia is an elevated level of potassium, a mineral and electrolyte, in your blood.…