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The administration has set a goal date of October 31 to complete a safety review, public comment period, and to take "appropriate action" in efforts to remove products from the market.

This FDA decision will help to improve clarity and diagnostic accuracy of echocardiograms in pediatric patients, according to GE HealthCare.

The in vivo hematopoietic stem cell-directed therapy received rare pediatric disease and orphan drug designations earlier this year.

"Early identification of high-risk neonates may enable targeted strategies to support respiratory health," stated the study investigators.