A new report reveals the FDA has allowed manufacturers to hide more than a million reports of serious injury and medical device malfunction away from public view since 2016.
A recent editorial published in the New England Journal of Medicine suggests that last year’s recall of St. Jude Riata defibrillator leads highlights ongoing problems with the FDA’s oversight of…
More than one out of every five heart defibrillators implanted in the United States may be unnecessary, or were implanted without their doctor following the appropriate guidelines for when the…
According to new research, the failure rate for recalled Medtronic Sprint Fidelis leads, which are small wires used to connect a defibrillator to the heart, could be twice as high…
The FDA has scheduled a public meeting for late this month to review review the controversial process used to swiftly approve medical devices, which some say has been overused and…
A new analysis by UBS Investment Research warns that the failure rate for Medtronic Sprint Fidelis defibrillator leads could reach as high as 30% over four years.
Two new studies have been published that are highly critical of the way the FDA approves medical devices for human use, saying that the agency requires too few clinical trials,…
A Minnesota judge has dismissed all state court lawsuits against Medtronic over its recalled Sprint Fidelis defibrillator leads. The decision follows a similar dismissal of the federal Sprint Fidelis litigation…
A panel of U.S. Senators heard testimony on Tuesday from patients and medical experts about the potential dangers of defective medical devices and the impact of a recent Supreme Court…
A Government Accountability Office (GAO) review of FDA’s oversight of medical devices has found a number of deficiencies that could expose the public to potentially dangerous and defective medical devices.…
