ivWatch said today that it won CE Mark clearance for its intravenous infiltration/extravasation monitoring device.
The company’s ivWatch Model 400, which has FDA clearance, is sold in the U.S. through group purchasing contracts with Premier and Vizient.
ivWatch also touted that it obtained ISO 13485:2016 certification through the Medical Device Single Audit Program.
“Peripheral IV therapy is among the most common invasive hospital procedures performed worldwide. Having the ability to extend the only surveillance monitoring technology for early detection of these common IV complications to new markets will help improve patient safety and effectiveness of IV therapy on a much larger scale,” president & CEO Gary Warren said in prepared remarks.
“Navigating the comprehensive process to secure these regulatory milestones not only makes ivWatch positioned for growth but gives us the ability to respond quickly to new opportunities,” he added.
The company’s sensor, which is roughly the size of a pencil eraser, uses light to measure the optical density of the tissue surrounding an IV insertion site, monitoring the flow of fluid as it moves into a person’s vein.
Earlier this month, ivWatch landed a medical device license from Health Canada for its technology.