A Medical Device Daily
The FDA reported the awarding of three grants to stimulate the development and availability of medical devices for children.
A panel of six experts with experience in medicine, business, and device development reviewed 16 applications for the grants, which will be administered by the FDA's Office of Orphan Products Development. The recipients and grant amounts include:
• James Geiger, MD, and the Michigan Pediatric Device Consortium, $1 million;
• Pedro DelNido, MD, and the Pediatric Cardiovascular Device Consortium, $500,000;
• Michael Harrison, MD, and the University of California at San Francisco Pediatric Device Consortium, $500,000.
Development of medical devices for children lags up to a decade behind similar devices intended for use in adults, according to the FDA. Children differ in terms of size, growth and body chemistry and present unique challenges to device designers. In addition, the activity level and ability to manage some implantable or long-term devices may vary greatly among children, the agency noted.
In other grants news, three new HealthPartners Research Foundation (Bloomington, Minnesota) studies will examine ways to prevent and treat childhood obesity and hypertension. One study will look at interventions to prevent obesity in children ages 5-9, another will focus on obesity prevention in children ages 2-5, while another will examine hypertension in children and adolescents, including the quality and cost of care.
The two studies on preventing obesity, "Healthy Homes/Healthy Kids: Pediatric Primary Care-Based Obesity Prevention," are led by Nancy Sherwood, senior research investigator at HealthPartners Research Foundation. Her team received a $3,765,000 grant from the National Institute of Diabetes and Digestive and Kidney Diseases (Bethesda, Maryland) to conduct the five-year study, which seeks to demonstrate the effectiveness of a low-cost intervention targeting obesity prevention in children. She also received $559,959 to study children ages 2-5.
A team led by Patrick O'Connor, PhD, senior clinical investigator at HealthPartners Research Foundation and assistant medical director at HealthPartners Medical Group, received a $3,036,000 grant from the National Heart, Lung, and Blood Institute (Bethesda, Maryland) to conduct its four-year study, "Childhood Hypertension and Obesity: Diagnosis, Care and Costs." The team will study the vital signs and clinical conditions of 80,000 children and adolescents with the goal of understanding their hypertension, carefully assessing how blood pressure is linked to being overweight, and assessing the quality of care provided.