Now that Boston Scientific, the maker of medical devices, has been publicly chastised by the FDA, its executives have taken a penitential tone. "It's clear we have not done enough to resolve the issues raised by the F.D.A., "a spokesman, Paul Donovan, said in a statement yesterday, "and we recognize fully that the responsibility to do so lies with us."Already, the F.D.A. has told Boston...
Boston Scientific fresh off its acquisition of Guidant Corporation, has been sent a warning letter by the FDA. Federal regulators said they discovered problems in the medical device maker's quality control. FDA officials who announced the warning involving Boston Scientific said it was only the third time in the agency's history it has issued such a broad companywide warning involving a...
According to an article published in the Minneapolis-St. Paul Business Journal Guidant heart devices have been linked to three new deaths. The information arose out of a Guidant report to the US Food and Drug Administration. The deaths occurred after Guidant had recalled the devices in June.
Under the Florida Statutes (FS 458.320) in order for a doctor to have hospital medical staff privileges the physician must meet certain financial requirements in order to pay medical malpractice judgments against the doctor for negligent medical care. However, the Florida Surpeme Court held a hospital has no duty to ensure a doctor complies with the statute.As a result of this court ruling, a...
An expert panel commissioned by Guidant Corporation to assess its handling of problems with cardiac medical devices cited the company for failure to properly assess patient safety. The commission noted that Guidant's decisions were guided by statistical projections provided by engineers rather than medical data provided by doctors. The group urged Guidant to create an outside panel of...
When Guidant Corp. came under fire last year for not revealing to doctors it's problems with its medical device, it remained positive in its public announcements. But newly released documents show that, inside Indianapolis-based Guidant, executives were struggling to contain a mounting crisis.The records illustrate how a series of miscalculations by Guidant, like its misreading of doctors'...
Showing items 71 to 76 of 76
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