FDA approves OTC handheld heart rhythm monitor
The FDA approved over-the-counter (OTC) sales and marketing of the HeartCheck Pen Handheld ECG, a handheld heart rhythm monitor manufactured by CardioComm Solutions.
The HeartCheck Pen takes heart readings in 30 seconds and can store up to 20 ECGs at a time, according to the Toronto-based health IT and ECG developer. After taking a reading, patients can view their heart rate count only when they consult with a physician, who can unlock stored data to display the real-time ECG and heart rate counts for subsequent heart rhythm recordings.
Also approved by the FDA was CardioComm Solutions’ GEMS Home software, which enables patients to upload data from the HeartCheck Pen to their personal computer and transmit it to a provider using CardioComm Solutions’ C4 ECG Management Service software.
The HeartCheck Pen takes heart readings in 30 seconds and can store up to 20 ECGs at a time, according to the Toronto-based health IT and ECG developer. After taking a reading, patients can view their heart rate count only when they consult with a physician, who can unlock stored data to display the real-time ECG and heart rate counts for subsequent heart rhythm recordings.
Also approved by the FDA was CardioComm Solutions’ GEMS Home software, which enables patients to upload data from the HeartCheck Pen to their personal computer and transmit it to a provider using CardioComm Solutions’ C4 ECG Management Service software.