REGULATIONS
Danvers, MA–based Abiomed has sought approval from the U.S. Food and Drug Administration to market its AbioCor artificial heart under a humanitarian-device exemption. Such an exemption would allow doctors to implant the heart, which has been tested on just 14 people so far, in not more that 4,000 patients suffering from end-stage heart failure.
MILESTONE
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Manufacturing in the United States is in trouble. That's bad news not just for the country's economy but for the future of innovation.
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