April 10, 2017
Chinese medical supply company Shenzen-Kingyield has received FDA 510(k) clearance for a Bluetooth-connected blood pressure monitor. The device is worn on the wrist and sends data to a smartphone for archiving or analysis, according to the clearance document, and the device has been cleared for over the counter sales. The company makes a variety of blood pressure monitors, blood glucose monitors...
May 20, 2014
Gauss's Triton Fluid Management system.
Back at the beginning of May, we reported on several mobile health FDA clearances from the previous month. But the FDA has been even busier than that, clearing at least three other big name mobile products in April, and a few more already in May.
First off, this month a couple of different iPad apps received FDA clearance. At the American Telemedicine...
February 19, 2014
Carestream has received FDA clearance for VUE Motion, a mobile radiology viewing and reading software that can be accessed on iPhone 4s, iPad 2, Galaxy Note and Galaxy S III mobile devices. Notably, the clearance allows radiologists to read, not just view the images, which means they can make clinical reports based on them.
"If a radiologist has access to other workstations, we recommend that...