Articles in the Medical Devices Category
Medical Devices »
On December 9th, Medtronic Inc. said that it had earlier received a subpoena from the Department of Health and Human Services seeking production of documents on a range of issues relating to the company’s heart-rhythm devices
FDA, Medical Devices »
The FDA found problems with procedures for preventing and identifying problems with its devices, documenting those problems, and the speed with which it informs the FDA of any issues
FDA, Medical Devices »
Federal regulators are demanding changes to labels on devices that deliver pain killers directly to joints after surgery, in response to numerous reports of irreversible cartilage damage
Medical Devices »
A Huntsville, Ala., company is recalling about 250 million Accusure insulin syringes it has distributed nationwide since January 2002 because the products’ needles could detach from the syringes
Medical Devices »
A medical technology company has been accused by federal prosecutors of fraudulently marketing devices used during spinal and bone surgeries
Litigation, Medical Devices »
A patient who was exposed to an overdose of radiation during a CT scan on Monday sued Cedars-Sinai Medical Center and the maker of the scanner.
Medical Devices, Product recalls »
Experts say deaths are the result of a major weakness in the nation’s system for recalling thousands of medical devices routinely implanted in people’s bodies, ranging from screws and plates to artificial knees and hips.
Medical Devices, Product recalls »
As reported in the San Francisco Chronicle, Philips Healthcare said Saturday it is recalling about 5,400 automated external defibrillators after receiving reports of a memory chip failure in a small number of some models that could make them inoperable.
FDA, Headline, Medical Devices, access to justice »
As noted in our Medtronic heart lead recall blog, the New York Times has issued a story that the U.S. FDA “has revealed that four New Jersey congressmen and its own former commissioner unduly influenced the process that led to its decision last year to approve a patch for injured knees,” an approval it is now revisiting.
FDA, Medical Devices »
The Food and Drug Administration is asking the government’s top medical advisers to review its system for approving certain types of medical devices, which has been criticized by safety advocates and government watchdogs.
