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FDA Chief Scientist Jesse Goodman is leaving the agency for Georgetown University and the D.C. Veterans Administration Hospital, where he will teach and practice medicine. 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
Medical device companies must include all core data elements for the unique device identification database except those marked “optional,” according to the International Medical Device Regulators Forum. Data elements marked “if applicable” are mandatory in the UDID if the information appears on the product label, IMDRF adds. Read More
Veterans Affairs medical centers should identify additional implants for coverage by VA-negotiated national committed-use contracts and set a timeline for expanding the volume of implants covered by these contracts, the General Accountability Office recommends in a new report. 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