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FDA Approves Heart Device From Wake Forest Startup

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WINSTON-SALEM, N.C. — WINSTON-SALEM, N.C. - MRI Cardiac Services has received Food and Drug Administration approval for the medical device it has developed that enables doctors to watch a beating heart.

The CardioVue device is designed to be used with MRI scanners.

MRI Cardiac Services is a start-up company from Wake Forest University Health Sciences.

"CardioVue gives the physician a unique tool to assist him in doing a real-time evaluation of the cardiac system of the patient," said S. Scott Huber, the company's president. "A key advantage of CardioVue is that it is designed to take a large volume of raw cardiac magnetic resonance images (MRI) and transform them into meaningful and actionable diagnostic information."

MRI images are downloaded to CardioVue, which allows a doctor to view the heart from multiple angles and look for abnormalities in the wall of the heart. The abnormalities could indicate a heart attack is in progress or has occurred, or that the heart is not receiving enough oxygen, the company said.

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