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NEW YORK/SAN FRANCISCO, JUNE 5, 2013—Dignitana, a world leader in medical scalp -cooling technology, announced today that it has received U.S. Food and Drug Administration (FDA) approval for its Investigational Device Exemption (IDE) application and is now free to initiate a highly anticipated multi-center, pivotal trial of the patented DigniCap® System. The trial is the second and final phase of study in the United States and paves the way for FDA market approval of the scalp-cooling device, which is already widely used overseas.
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