A first-of-a-kind medical device has been approved to treat babies born with moderate-to-severe hypoxic-ischemic encephalopathy (HIE), a potentially fatal injury to the brain caused by low levels of oxygen. The Olympic Cool-Cap system, approved by the FDA in December 2006, is designed to prevent or reduce damage to the brains of these babies by keeping the head cool while the body is maintained at a slightly below-normal temperature.

"This approval brings new hope to parents of the approximately 5,000 to 9,000 babies each year who are born in the United States with moderate to severe hypoxic-ischemic encephalopathy," says Daniel Schultz, M.D., director of the FDA's Center ...