Posts Tagged 'Food and Drug Administration'

Federal officials, doctors concerned over GranuFlo allegations

Health care providers and federal health regulators have voiced concerns, following revelations that the United States’ largest operator of dialysis centers may have concealed reports that one of its products carries a potentially deadly risk.

A New York Times report quotes Steven Silverman, director of compliance for the U.S. Food and Drug Administration’s medical devices division, as saying: “Candidly, I just think it’s bad business and not ...

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At-home dialysis helps quality of life

The East Montgomery County Observer tells the story of a 27-year-old man with kidney failure, whose quality of life was greatly improved when he began using a portable, in-home dialysis system.

He previously had to make a long drive and arrive at a dialysis center at 5 a.m. in order to finish the 4-hour treatment, then make it to work on time. Doctors told him that routine would be necessary three ...

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Ultrasound can help prevent heart deaths in dialysis patients

A report in U.S. News and World Report says ultrasound can detect fluid in the lungs of dialysis patients, which may help prevent fatal heart problems.

Researchers have concluded that fluid in the lungs is a better predictor of the risk of dying or having a heart attack than other symptoms of heart failure.

Patients undergoing kidney dialysis are at risk of heart failure. In some cases, the dialysis itself may be ...

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FDA investigates dialysis company Fresenius

Fox News reports that the U.S. Food and Drug Administration has issued a warning to Fresenius Medical Care, a German company that manufactures kidney dialysis equipment and operates dialysis centers.

The agency’s warning letter alleges that Fresenius failed to adequately test artificial kidneys — called “dialyzers” – manufactured in Utah, to make sure they adequately meet design specifications.

The FDA stopped short of issuing a recall in this case. But the ...

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