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ivWatch's Model 400 device gets FDA approval to monitor IV therapy in pediatric patients

Published 09 January 2017

Medical device firm ivWatch has secured 510(K) clearance from the US Food and Drug Administration (FDA) for its Model 400 medical device to monitor intravenous (IV) therapy in pediatric patients.

The ivWatch Model 400 will continuously monitor patient's IV for the early detection of infiltrations, when medication or fluid leaks outside the vein into the surrounding tissue.

The device has been currently approved to monitor patients aged 17 and below, while it secured FDA clearance for patients 18 years and older in February 2015.

Model 400 features noninvasive sensor, which uses near-infrared light to detect changes in the optical properties of tissues.

The device is said to notify clinicians if conditions suggest an infiltration, helping them to reduce address the issue early to help reduce patient harm.

ivWatch chief medical officer Dr Brian Clare said: "We are excited to be able to offer the ivWatch Model 400 for pediatric patients to enable children's hospitals and other facilities catering to pediatrics another measure of protection for the early detection of IV infiltration or extravasation events."

ivWatch president and CEO Gary Warren said: ""When we received our first FDA clearance, I stated our goal was to be on every IV pole in the country and provide continuous monitoring of every IV placed.

"Our ability to offer our product to both adult and pediatric patients takes us one step closer to that goal and solving this significant health care problem."


Image: Pediatric patient with the ivWatch Model 400 for the early detection of peripheral IV infiltrations. Photo: courtesy of PRNewsFoto / ivWatch, LLC.