CardioComm out of Victoria, Canada received marketing clearance from the FDA to bring its HeartCheck Pen Handheld ECG to the U.S.
The device can be used by the patients themselves at home and comes with software the allows recorded telemetry to be uploaded to the company’s C4 medical call service telemedicine group where physicians can analyze the data.
Features from the product page:
• easy to use
• accurate heart readings in only 30 seconds
• Store up to 20 ECGs
• ECGs can be printed or downloaded to a computer
• ECGs can be monitored remotely by a physician, clinic, or ECG co-ordinating centre.
Product page: HeartCheck Pen Device
Press release: CardioComm Solutions, Inc. Receives FDA Clearance to Market First Over-the-Counter Heart Monitoring Solution