FDA Awards 510(K) Clearance to ivWATCH for Continuous Monitor

The medical device manufacturer ivWatch garnered an FDA 510(k) clearance for the use of its ivWatch Model 400 in pediatric patients under the age of 18.

The continuous monitor for a patient’s IV detects medication or fluid leaks outside the vein into surrounding tissue. It uses a noninvasive sensor to collect near-infrared light and detect changes in the tissue to notify clinicians of potential infiltration.

In February 2015, the FDA cleared the device for patients 18 years and older.