Hampton, Va.–based ivWatch has started to market its IV monitor to pediatric patients, a month after receiving FDA 510(k) clearance for its Model 400 patient IV monitor for patients aged 17 and under.
The company previously received clearance in February 2015 for patients aged 18 and under. The Model 400 has been in research and development since 1999.
“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,” Dr. Brian Clare, ivWatch’s chief medical officer, said in a news release.
The continuous patient IV monitor is specifically designed for patients under the age of 18. The ivWatch Model 400 is a noninvasive sensor that uses near-infrared light to identify optical light changes in patient tissue. The sensor is used with a pole-mounted patient monitor and notifies clinicians if there is an infiltration in enough time to reduce harm.
Pediatric patients are at risk for infiltration because of their size and movement, according to ivWatch. The flexible cable allows patients to safely move around and uses signal processing techniques to account for patient motion and reduce alarm fatigue.
About 90% of all hospital patients receive a peripheral IV and 23% have IV failures due to the leaking of fluid or medication in the tissue surrounding the vein, known as infiltration, according to ivWatch
“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,” said Gary Warren, president and CEO of ivWatch. “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.”
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