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.
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Lupin launches Dasatinib tablets in US market
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA
FDA approves Tenpoint Therapeutics' YUVEZZI as first dual-agent eye drop for presbyopia
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
WuXi Biologics collaborates with Sinorda Biomedicine for antibody development
Biogen's litifilimab receives FDA Breakthrough Therapy Designation for CLE
Glaukos receives FDA approval for repeat administration of iDose TR
Guerbet's contrast agent Elucirem approved by European Commission in children from birth
Spine Innovation's LOGIC Titanium Implant System receives US FDA 510(k) market approval