San Francisco-based AliveCor won FDA clearance to sell its smartphone heart monitor without a prescription for the 1st time, moving the device into a growing realm of self-tracking apps for the consumer market.
AliveCor is now taking pre-orders for the device, which was previously available only via prescription, and the shipments are expected to begin in March, according to a company statement.
The AliveCor heart monitor, going for about $200, is available for both iPhones and certain Android devices. The app sends readings to the company’s AliveInsights analysis system, where a live cardiac technician or cardiologist reviews the data and sends back a report in about half an hour.
With OTC clearance, the device now fits alongside other self-tracking apps that have made headlines in recent months. This year’s highly anticipated Consumer Electronics Show featured headbands that analyze brain waves and socks that monitor everything from weight distribution to speed, as well as other devices designed to record and analyze personal biometric data.
"Over-the-counter access to mobile health devices has the potential to change the way consumers manage their overall health, facilitate preventative medical care and save both patients and healthcare professionals time," AliveCor president & CEO Euan Thomson said in prepared remarks. "We are pleased to now provide easier access to our innovative Heart Monitor and with the help of healthcare professionals provide timely analysis of data to all users."