Study: Abbott, Edwards may have mislabeled hundreds of patient deaths

By

Abbott (NYSE:ABT) and Edwards Lifesciences (NYSE:EW) may have mislabeled patient deaths as injuries or device malfunctions in hundreds of FDA adverse event reports involving their transcatheter aortic or mitral valve replacement devices, according to a new study.

The study by JAMA Internal Medicine editor Dr. Rita Redberg, former FDA unique device identification (UDI) external program manager Madris Tomes and others examined a total of 10,558 adverse event reports related to Abbott’s MitraClip or Edwards’ Sapien 3 devices from the time the FDA approved them through December 2018.If you want to read more about this news, click here.

Posted in News.
Share

Deja una respuesta

Tu dirección de correo electrónico no será publicada.

Related Posts

  •
    10 octubre, 2019

    ‘Electronic tongues’ may help diagnose early stage bladder cancer

    New research presents a complex electronic device as a possible new, efficient, simple, and cost-effective way of detecting bladder cancer in its early stages and monitoring people living with bladder cancer. In a quest to find a better way of diagnosing bladder cancer, Spain-based researchers from the Polytechnic University of Valencia (UPV), the La Fe …

  •
    18 junio, 2019

    Stroke significantly increases the risk of dementia

    In the largest study of its kind, researchers conclude that stroke doubles the risk that an individual will eventually develop dementia. If you want to read more about this news click here.

  •
    30 diciembre, 2019

    Finding a non-invasive way to predict effectiveness of cancer therapy.

    «Researchers have taken a critical step toward developing a non-invasive nuclear medicine technique that can predict the effectiveness of therapy for cancerous tumors, allowing for personalized, precision treatment.» Read more.  

  •
    18 junio, 2019

    New York Times calls for tightened medical device regulation from FDA

    The New York Times last Friday released an editorial calling for improved regulation on medical devices from the FDA, citing a number of recent controversial devices that have made headlines for injuries and deaths related to their use.  If you want to read more about this news click here.