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

Potassium screening mHealth device - Blood Test - Needle

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.…

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