May 1, 2014
Vital Connect's HealthPatch
This past month the FDA cleared two mobile medical apps and one digital health platform as 510(k) Class II medical devices.
McKesson, one of the most vocal health IT companies lobbying for changes to how the FDA regulates medical software, secured clearance for a mobile medical app called McKesson Cardiology ECG Mobile. The web-based version of McKesson Cardiology...
July 22, 2013
This month the FDA cleared Westborough, MA−based Reflectance Medical's noninvasive, peel-and-stick sensor for measuring muscle oxygen saturation (SmO2) and pH (pHm), an indicator of tissue acidosis. Reflectance's Multi-Parameter Mobile CareGuide 3100, which simultaneously and continually measures those two parameters, secured Class II clearance. Quickly reversing acidosis can help prevent serious...