Tag Archives: regulation

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British Recall of Smith & Nephew Renasys Wound Care System

British Recall of Smith & Nephew Renasys Wound Care System for Infection Risk

The MHRA announced the recall of Smith & Nephew Renasys wound care devices - risk of maceration, infection, loss of negative pressure, or unrecognized bleeding in wounds.

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Canadian Study Finds Actos Raises Bladder Cancer Risk by 22 Percent

Yet another study is confirming the association between the diabetes drug, Actos, and bladder cancer. This latest research, published today in the Canadian Medical Association Journal, found that taking Actos raised the risk of bladder cancer among diabetics by about one-fifth.

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FDA Advisors Set to Examine Metal-on-Metal Hip Implant Safety Concerns

Thousands of people with metal-on-metal hip implant devices could soon get some answers from the U.S. Food & Drug Administration (FDA) about the dangers they face. Tomorrow, the agency will convene a panel of outside medical experts to examine the safety record of metal-on-metal hip replacements, and recommend the ...

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Federal Judge Certifies Medtronic Infuse Shareholder Class Action Lawsuit

A shareholder lawsuit alleging Medtronic Inc. illegally promoted the off-label use of its Infuse bone growth product has been granted class action status by U.S. District Judge Paul Magnuson of Minnesota. According to a report from Law360.com, the Medtronic Infuse off-label promotion lawsuit was filed by several institutional investors on ...

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What Action Will the FDA Take on E-cigarettes?

What Action Will the FDA Take on E-cigarettes?

As health and quality concerns trouble the e-cigarette industry, experts and the public await the Food and Drug Administration (FDA)’s action to regulate the devices.

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Medtronic Sprint Fidelis Leads Vulnerable to Fracture after ICD Switch

Medtronic Sprint Fidelis leads are vulnerable to fracture following ICD switch, says a new study published in the June issue of the journal Heart Rhythm.

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Tentative Ohio Fracking Regulations Criticized as too Lax

Lawmakers in Ohio have tentatively passed new regulations governing hydraulic fracturing (fracking) drilling but they’ve immediately been criticized for being too favorable to the natural gas and oil industries.

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FDA Metal-On-Metal Hip Replacement Investigation Is Flawed, Researchers Say

The U.S. Food & Drug Administration’s (FDA) metal-on-metal hip replacement investigation is flawed, according to researchers.

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First Bard Avaulta Transvaginal Mesh Lawsuit Scheduled for February Trial in MDL

The first test trials in the federal C.R. Bard Avaulta transvaginal mesh litigation will most likely start next year, according to a report from Bloomberg News. About 600 lawsuits involving Bard Avaulta transvaginal mesh products are currently pending in the multidistrict litigation underway Charleston, West Virginia. U.S. District Judge Joseph ...

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Smokers More Vulnerable to Joint Replacement Failures

People who smoke cigarettes before and after receiving a total joint replacement, such as a hip replacement device or knee implant, are far more likely to endure revision surgeries on those implants than people who don’t smoke.

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CarMax Accused of Selling Cars with Lethal Safety Defects; Senator Seeks Tighter Regulation

U.S. Sen. Richard Blumenthal has proposed new legislation to regulate the sale of used cars with unrepaired recalls with what he says can be lethal safety defects. Blumenthal, the senior senator from Connecticut, is concerned about cars sold by CarMax. … Continue reading

Posted in Defective Products, Motor Vehicles, Product Recalls, Recalled Vehicles | Tagged , , , , |

Congresswoman Calls for FDA Regulation after Veteran is Injured by Exploding E-Cigarette

Congresswoman Calls for E-Cigarette FDA Regulation

The use of electronic cigarettes has been on the rise in their short time on the market. While they are touted as being a safer alernative to traditional cigarettes and as a cessation tool, there are still public health and … Continue reading

Posted in Legal News | Tagged , , , , |

Legislation Before Congress Would Weaken Testing and Regulation of Medical Devices

Legislation Would Weaken Regulation of Medical Devices

In a time when ever-increasing numbers of Americans rely on medical devices, legislation currently before Congress could weaken the standards the Food and Drug Administration (FDA) uses to determine a device’s safety and efficacy. The 21st Century Cures Act would … Continue reading

Posted in Defective Medical Devices, Health Concerns | Tagged , , , , |

Health Experts Urge FDA to Act Quickly on E-Cigarette Regulations

Experts Urge FDA to Act Quickly on E-Cigarette Regulations

The Food and Drug Administration (FDA) has yet to finalize proposed regulations on e-cigarettes that it issued a year ago, prompting concern among health experts about the delay. A coalition of 31 health and medical groups including the American Academy … Continue reading

Posted in Health Concerns, Toxic Substances | Tagged , , , , |

Former FDA Commissioner Says Agency Needs to Regulate E-Cigarettes

Former FDA Commissioner Says E-Cigarette Regulation Needed

The U.S. Food and Drug Administration (FDA) is facing mounting pressure to regulate e-cigarettes after the federal government recently announced that use of the devices has tripled among young people within one year. Even though the agency has had the … Continue reading

Posted in Health Concerns, Legal News | Tagged , , , , , , |

Two Leading Cancer Groups Issue Call for Regulation of E-cigarettes and Research on Health Risks

Cancer Groups Call for E-cigarettes Regulation/Research

In a joint statement, the American Society of Clinical Oncology and the American Association for Cancer Research have called on the federal government to move quickly to regulate e-cigarettes and increase research on their health effects. These leading research and … Continue reading

Posted in Arcadia Ohio Norfolk Southern Train Derailment, Health Concerns, Toxic Substances | Tagged , , , , |

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