FDA grants "humanitarian exemption" for heart device

02/27/2004 | Yahoo!

The FDA has given the makers of a miniature heart device an exemption from directly proving the device is safe in children because the device can help keep children alive while they are waiting for a heart transplant. The exemption was granted for Houston-based MicroMed Technology's specially designed left ventricular assist device, which helps keep a dying heart pumping.

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