William Maisel News
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External defibrillators, devices that shock hearts back into normal rhythms, will face tougher U.S. regulations under a proposal designed to cut down on the number of malfunctions.
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Johnson & Johnson and C.R. Bard Inc. must study rates of organ damage and complications linked to vaginal mesh implants, U.S. regulators said, responding to patient advocates who say the devices have harmed women.
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Johnson & Johnson and C.R. Bard Inc. must study rates of organ damage and complications linked to vaginal mesh implants, U.S. regulators said, responding to patient advocates who say the devices have harmed women.
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High-risk medical devices are approved for sale without sufficient proof of safety by U.S. regulators who don’t monitor recalls when concerns arise during marketing, the Government Accountability Office found.
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Johnson & Johnson and rival makers of transvaginal meshes told Food and Drug Administration advisers they agreed on the need for more safety studies of the implants as well as labeling changes to warn of potential risks.
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The U.S. Food and Drug Administration warned doctors and patients against the use of an unproven procedure known as “liberation therapy” that some physicians have touted as a treatment for multiple sclerosis.
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A mobile medical-imaging application won approval from U.S. regulators to let doctors examine pictures from patient scans on Apple Inc. ’s iPhone and iPad.
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Allergan Inc. and Johnson & Johnson breast implants were linked in a U.S. review to a rare type of cancer, challenging again the safety of the decades-old products.
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Medical device makers Medtronic Inc. , Johnson & Johnson and Stryker Corp . face new safety rules under a revamped program laid out by U.S. regulators that may help speed approval of products from condoms to CT scanners.
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