mobile medical app

FDA clarifies the line between wellness and regulated medical devices

By Brian Dolan 05:39 am January 16, 2015

As promised in its FDASIA report, the FDA has published a draft guidance document that aims to help those creating wellness devices and apps to better understand when their product (or their marketing claims) crosses over into regulated medical device territory. As always the agency is seeking comment from the industry and the public on their new draft guidance for the next 90 days. "A general...

iHealth unveils wearable ECG, pulse ox, BP devices

By Brian Dolan 11:34 am January 7, 2014

iHealth's not yet FDA-cleared wearable ECG device Mountain View, California-based iHealth Lab, a subsidiary of Chinese medical device company Andon Health, showed off three new smartphone-enabled, wearable health devices at CES in Las Vegas this week: a blood pressure monitoring vest, an ambulatory ECG device that sticks to the wearer's bare chest, and a wristworn pulse oximeter device. None...