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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
Even as more and more healthcare is moving into the home, manufacturers and other stakeholders remain ill-prepared to serve that patient population. That’s the conclusion of a new report by the Association for the Advancement of Medical Instrumentation. Read More
Lawmakers said they will work to eliminate the Physician Payment Sunshine Act’s requirement that devicemakers disclose gifts of medical journal reprints and textbooks to physicians after the Centers for Medicare & Medicaid Services refused a request to reverse the policy. Read More
Aligning Medicare payment rates for vacuum erection systems with those of other insurers could have saved the government $14.4 million and beneficiaries about $3.6 million yearly over a six-year period, a new report by HHS’ Office of Inspector General concludes. Read More
The FDA’s new custom device exemption, granted under FDASIA, does not apply to 510(k)-cleared devices that are modified but still retain their original intended use and could be clinically studied, the agency clarifies in a draft guidance. Read More
The FDA’s budget would be set at $4.35 billion, an increase of $91 million from 2013, under an omnibus spending bill passed by Congress last week. Read More
While all FDA device investigators go through specialized training, combination products and foreign inspections can still pose challenges during the inspection process. Read More