Emmes Announces FDA Clearance of New Medical Device
The New "Mercy TAPE" Estimates Pediatric Weight with Greater Accuracy, Giving Doctors a Better Tool for Determining Prescription Dosage
ROCKVILLE, Md., May 20, 2015 /PRNewswire/ -- The Emmes Corporation today announced that the U.S. Food and Drug Administration (FDA) has given marketing clearance for a new device that allows doctors to more accurately assess children's weight without the use of a weight scale. Weight estimates are used in emergency situations and in developing countries where scales may not be available. This new device will allow doctors to determine with greater accuracy the prescription dosage levels needed for children with a range of illnesses and across a variety of settings throughout the world.
The device was developed by Dr. Susan M. Abdel-Rahman at Children's Mercy Hospitals and Clinics (CMH) of Kansas City, Missouri. A patent was awarded to CMH in November 2013. Now with the FDA clearance, the device now can be marketed worldwide.
Emmes coordinated and analyzed the study on 624 participants ranging in age from 2 months to 16 years. The FDA marketing clearance was based on this study, titled Mercy TAPE: Taking the guesswork out of Pediatric weight Estimation. Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development through its Pediatric Trials Network (PTN), the study was a collaborative effort between the PTN operated by Duke Clinical Research Institute, CMH and Emmes under an initiative called the Best Pharmaceuticals for Children Act. Emmes also prepared the regulatory application to FDA on behalf of CMH.
The study found that for 76% of U.S. children in the study, the Mercy TAPE's estimates came within 10% of their actual weight. The results were within 20% of actual weight in 98% of children. Other studies showed that it performed with similar accuracy for children in Africa and South Asia.
Following the completion of the study, results were presented at the Pediatric Academic Societies' annual meeting in April 2013, with a paper published the same month in Annals of Emergency Medicine.
"This is a perfect example of a successful client collaboration with far-reaching potential impact," noted Dr. Anne Lindblad, president and chief executive officer of Emmes. "It involved two government agencies – the NIH and FDA – along with a world renowned research institute and one of the country's top pediatric medical centers. We're thrilled to be able to support the development of a new, easy-to-produce and use device that will improve the ability of doctors to quickly and accurately assess the weight of children in order to determine the appropriate prescription dosage levels."
She added,"We are proud to have had the opportunity to bring an FDA-cleared device to the public. This success complements our existing long history of clinical trials and research studies that support government, non-profit and commercial clients."
We collaborate with our clients to produce valued, trusted scientific research. Our team members at Emmes are passionate about making a difference in the quality of human health, and we have supported more than a thousand studies across a diverse range of diseases since our formation in 1977. Our research is contributing to a healthier world. For more information, visit www.emmes.com.
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SOURCE The Emmes Corporation