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Devicemakers using material from animals that could carry transmissible spongiform encephalopathies should document the absence of TSE disease and standard vaccinations, such as live modified viruses, that the animal received, an updated FDA guidance says. Read More
The U.S. Supreme Court Wednesday unanimously ruled that patent holders must prove infringement, even in cases where a licensee initiated the litigation. Read More
Wall Street analysts and HeartWare International are blaming a recent change in Medicare’s national coverage policy on ventricular assist devices for the company’s less-than-stellar fourth quarter earnings. Read More
A Delaware federal district court jury ruled Wednesday that Medtronic willfully infringed an Edwards patent with its CoreValve transcatheter aortic valve replacement, awarding Edwards $392.5 million in damages and royalties. Read More
The Justice Department recovered about $2.6 billion in healthcare-related False Claims Act settlements and judgments in fiscal 2013, a drop from the previous year’s total of $4.2 billion. Read More