This week the US Food and Drug Administration sent a letter to Mountain View, California-based Biosense Technologies, maker of the uChek smartphone-enabled urinanalysis system, that instructs the company to seek 510(k) clearance of its mobile medical app or convince the FDA that such a clearance is not necessary. Sending an "it has come to our attention letter" like this is a rare action for the...
iHealth's original Blood Pressure Cuff for iOS users
iHealth Lab, a subsidiary of China-based Andon Health, just received 510(k) clearance from the FDA for a wrist-worn, Bluetooth-enabled blood pressure monitor called the iHealth BP7 Wireless Blood Pressure Wrist Monitor that will connect with iPhones, iPads, and iPod touch devices.
The original iOS-enabled iHealth blood pressure cuff, which...
