Sanket S. Dhruva

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BACKGROUND Unlike prescription drugs, medical devices are reviewed by the US Food and Drug Administration (FDA) using 2 alternative regulatory standards: (1) premarket approval (PMA), which requires clinical testing and inspections; or (2) the 510(k) process, which requires that the device be similar to a device already marketed (predicate device). The(More)
CONTEXT Medical devices are common in clinical practice and have important effects on morbidity and mortality, yet there has not been a systematic examination of evidence used by the US Food and Drug Administration (FDA) for device approval. OBJECTIVES To study premarket approval (PMA)--the most stringent FDA review process--of cardiovascular devices and(More)
BACKGROUND Cardiovascular devices can have different safety and effectiveness profiles in men and women. The type and quality of sex-specific data reviewed by the Food and Drug Administration (FDA) before approval of these devices are unknown. METHODS AND RESULTS We performed a systematic review of the demographics, comments on gender bias, and analysis(More)
OBJECTIVE To investigate characteristics of clinical trials and results on safety and effectiveness reported in US Food and Drug Administration (FDA) documents for recently approved high risk cardiovascular devices compared with the characteristics and results reported in peer reviewed publications. DESIGN A search of the publicly available FDA database(More)
BACKGROUND There is a paucity of data on the adequacy of the resources and tools used by the Centers for Medicaid and Medicare Services (CMS) in making national coverage determinations about services for beneficiaries. The objective of this study was to determine the extent to which clinical trials relied on by the CMS are applicable to Medicare(More)
2699 their salary and would serve for 2 years with the corps. In addition, the fiscal year 2010 budget includes $169 million for the NHSC — an increase of $34 million from fiscal year 2009 — for recruitment and retention of primary care physicians, as well as dentists and other health care professionals. As a result, the NHSC’s “field strength” is projected(More)
Anesthetic agents are sometimes added to the wrong vaporizer on an anesthesia machine. As a result, the vaporizer may deliver a mixture of anesthetic agents at concentrations inappropriate for use on a patient. However, untoward clinical complications related to vaporizers can be prevented with a time-shared mass spectrometer. This device accurately and(More)
was the standard of care. In 2002, a novel hysteroscopic sterilization device was made available after expedited review and premarketing approval by the Food and Drug Administration (FDA): the Essure System (Bayer). With Essure, a coil designed to induce fibrosis and tubal occlusion is placed into each fallopian tube to prevent fertilization. Three months(More)