A number of digital health devices have recieved FDA 510(k) clearance in the last month, including a number of apps and devices in the cardiac health space. Some clearances are updates to companies that have one or more existing clearances, while some are newly cleared devices. Read on for a roundup of connected ECG sensors, medical device companion apps, and wearable patches.
1. St. Jude Medical...
EPI Mobile Health Solutions, a Singapore-based company, has received FDA clearance for a smartphone-enabled ECG device -- one which the regulatory agency refused to import last fall. The company claims on its website to be "the world’s first, patented Electrocardiogram ('ECG') function integrated onto a mobile phone," likely referring to its EPI Life mobile phone offering. EPI Mobile Health has...
Cardiac Designs' FDA-cleared ECG Check, not yet commercially available.
A new ECG device for the iPhone 4s called ECG Check received over-the-counter clearance from the FDA last month. The device, which would be the first product from Park City, Utah-based Cardiac Designs, appears very similar to the AliveCor Heart Monitor, which is currently only cleared for prescription use. The device was...
