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Defibtech, a manufacturer of automatic external defibrillators (AEDs), has announced a worldwide voluntary recall of two models of AEDs due to a software problem.
Rep. Henry Waxman (D-Calif.), chairman of the House Oversight and Government Reform Committee, has sent letters to Boston Scientific and Johnson & Johnson (J&J) asking the firms for information on their drug-eluting stents.
An advisory panel has recommended against FDA approval for an implantable heart-monitoring device until the sponsoring firm can conduct a larger trial.
Gebauer, a 107-year-old medical device manufacturer and marketer, has announced a nationwide, voluntary firm-initiated recall of certain lots of its Salivart Oral Moisturizer, product number 0386-0009-75.
Sens. Edward Kennedy (D-Mass.) and Gordon Smith (R-Ore.) introduced the "Laboratory Test Improvement Act," which will mandate that all providers of laboratory-developed, or "homebrew," tests provide the FDA with evidence of the tests' analytical and clinical validity.
AdvaMed has reached an agreement with the FDA on user fees through negotiations on the reauthorization of the Medical Device User Fee and Modernization Act.