ivWatch said today that it landed a medical device license from Health Canada permitting the sale of its intravenous infiltration/extravasation monitoring device.
The company’s FDA-approved 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.
“We have done so many clinical studies that we know how the density changes the tissue and what it looks like when it’s leaking outside the vein,” CEO Gary Warren told Drug Delivery Business News earlier this year. “We map those signals that we get, in real time, to a huge database of what an infiltration or extravasation looks like, so we can determine if the IV is leaking or not.”
“This is yet another milestone allowing more medical care providers and patients access to a first-of-its-kind technology to minimize harm from peripheral IV infiltration/extravasation events (PIVIEs),” Scott Hensley, VP of sales & business development, said in prepared remarks. “Canada is one of the most progressive healthcare markets in the world and acknowledge PIVIEs as serious safety events. Clinicians understand the need for surveillance monitoring to improve patient safety.”