Research & Development
Emmes passes FDA approval for the Mercy babyTAPE medical device for the estimation of weight of infants
7 January 2020 -

Health company Emmes revealed on Monday that the US Food and Drug Administration (FDA) has cleared its prescription-only medical device, called the Mercy babyTAPE, to estimate the weight of infants who are up to 90 days of age.

The company said the Mercy babyTAPE is a tape-measure-like device that permits health care professionals to estimate the body weight of preterm and full-term infants when a scale may not be available or practical to use. This easy-to-produce device could be especially useful in emergency or resource-constrained situations in remote or rural areas and in developing countries.

According to the company, the Mercy babyTAPE was developed under the Best Pharmaceuticals for Children Act, which mandates the National Institutes of Health (NIH) to prioritize therapeutic areas in critical need of pediatric-specific treatment information, sponsor pediatric clinical trials and submit the data for review by the US Food and Drug Administration (FDA) for action on affected products.

Based on the analysis of the data from the company's NIH-funded studies for the original Mercy TAPE devices, the first weight estimation devices were developed under the BPCA programme and were cleared by the FDA. The Mercy babyTAPE now brings the same weight estimation process to infants.

All the Mercy TAPE devices were developed by Dr Susan M. Abdel-Rahman at The Children's Mercy Hospital of Kansas City, Missouri.



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