St. Jude Warns Of Battery-Depletion Issues With Some ICDs
St. Jude Medical has issued a warning about premature battery depletion issues in some ICDs, but says it has already fixed the problem. Analysts say it is not likely to have any impact on Abbott’s plans to acquire St. Jude by the end of 2016.
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House Energy and Commerce Committee members added a slate of industry-favored device amendments into the FDA Reauthorization Act before sending the bill to the chamber floor, including reforms targeting device accessories, medical imaging and post-market surveillance.
US FDA's Gottlieb Wants Safety Built Into New Medtech Products, But Budget Will Be Cut To Surveil Older Ones
President Trump's proposed budget cuts to the agency's post-market surveillance programs means that more "faulty" devices, such as St. Jude defibrillators and Bayer HealthCare's Essure birth control coils, will cause harm rather than be recalled, Rep. Rosa DeLauro said at a May 25 House Ag/FDA subpanel hearing. FDA Commissioner Scott Gottlieb told DeLauro the agency needs to supply "the right tools" to firms during device development so similarly flawed devices aren't put on the market, and he noted that the lifting of a hiring freeze at the agency earlier in the day would free the agency to work harder on such issues.
FDA investigators are concerned Abbott's St. Jude Medical subsidiary failed to adequately address concerns over cybersecurity vulnerabilities and premature battery drain on their cardiac devices manufactured at its Sylmar, Calif., facility.