FDA Clears Medical Device for IV Monitoring in Pediatric Patients


The ivWatch Model 400 for pediatric patients is now available in the United States.

The ivWatch Model 400 for pediatric patients is now available in the United States. The device is a continuous monitor for a patient’s IV and provides early detection of an infiltration. This comes after the FDA provided 510(k) clearance for use in patients 17 years old and younger in December 2016. The product has was cleared by the FDA for patients 18 years and older in February 2015.

Although peripheral IVs are one of the most common medical invasive procedures performed in the United States each year, their failure rate is more than 20% due to infiltration.

“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,” Brian Clare, MD, Chief Medical Officer at ivWatch, said in a press release.

Pediatric patients may be at a higher risk of infiltration due to their body size and movement. The ivWatch Model is designed to be an affordable, risk-reducing option for pediatric hospitals and physicians.

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