ivWatch Receives CE Mark for the ivWatch Model 400

ivWatch, the only provider of continuous monitoring devices for the early detection of intravenous (IV) infiltrations and extravasations, has announced the CE marking of the ivWatch Model 400. In addition to conforming to European standards, the company obtained ISO 13485:2016 Certification through the Medical Device Single Audit Program (MDSAP), a global standard for medical device quality management systems. The first-of-its-kind and U.S. Food and Drug Administration (FDA)-cleared device is currently sold in the United States through direct sales by ivWatch utilizing group purchasing contracts from Premier and Vizient, Inc.
 
“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,” said Gary Warren, president and CEO of ivWatch. “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.”
 
MDSAP enables medical device manufacturers to contract with an authorized third-party auditing organization to conduct a single audit which satisfies all regulatory authorities in a given market. In addition to the FDA, other authorities participating in the program include those in Australia, Brazil, Canada, and Japan. These achievements come only weeks after ivWatch was issued a medical device license by Health Canada, and supports an ongoing licensing and distribution partnership with Terumo Corporation in Japan.
 
Because the ivWatch Model 400 continuously monitors the IV site, it offers a significantly improved measure of security to a standard, unmonitored peripheral IV, thereby also reducing costs associated with wasted medications and adverse events. Reliable early detection and notifications of infiltration is the next step for improving patient outcomes during IV therapy.
 
ivWatch, LLC is a medical device manufacturer and biosensor technology company focused on improving patient safety and the effectiveness of intravenous therapy. It focuses on eliminating patient harm caused by infiltrations and extravasations. Through innovative monitored IV solutions, the company helps minimize the risks associated with adverse IV events.