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"Previous adult heart assist devices were too large to be used in critically ill children to keep them alive while they wait to get a new heart," said Susan Cummins, MD, MPH, chief pediatric medical officer in the FDA's Center for Devices and Radiological Health, in a statement.
"This is a step forward, it is the first FDA-approved pulsatile mechanical circulatory support device specifically designed for children," said Susan Cummins, chief pediatric medical officer in the FDA's Center for Devices and Radiological Health.
"Children are not small adults. This pediatric face mask helps fill an unmet need for medical devices that are specifically designed for children's unique anatomy and growing bodies," Susan Cummins, MD, of the FDA's Center for Devices and Radiological Health said in a statement.