FDA 510(K) clearances

By Jonah Comstock 08:58 am July 8, 2013
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...
By Brian Dolan 04:40 am August 14, 2012
August is not yet half over and already the FDA has had a busy summer. In recent weeks MobiHealthNews reported on the FDA's de novo clearance of Proteus Digital Health's intelligent medicine platform and Asthmapolis' inhaler sensor and companion software. As we noted early last month, the FDA granted 510(k) clearance to a variety of digital health companies in June, including the app-enabled...
By Brian Dolan 07:35 am January 20, 2012
The Duofertility Reader Late last year the US Food and Drug Administration (FDA) cleared Duofertility, a computerized basal body temperature thermometer developed by Cambridge Temperature Concepts, with a 510(K). Cambridge Temperature Concepts developed the device, which is intended for use in measuring and recording basal body temperature as an aid in ovulation prediction to aid in conception,...