Medical Devices

  • Read more: TeleSitters are entering hospital rooms. How will they change patient care?
    Article

    TeleSitters are entering hospital rooms. How will they change patient care?

    By Adriana Krasniansky In many medical circumstances, clinicians and caregivers may choose not to leave a patient alone. For example, a patient may present a fall risk, experience confusion and agitation, or be at risk of self-harm.  Traditionally, in such situations, a hospital assigns the patient a sitter, or a caregiver who provides patients patient…

  • Read more: Why Medical Device Regulation?
    Article

    Why Medical Device Regulation?

    By Carmel Shachar The Petrie-Flom Center’s 2020 annual conference, Innovation and Protection: The Future of Medical Device Regulation, co-sponsored by the University of Copenhagen’s Center for Advanced Studies in Biomedical Innovation Law and the University of Arizona Health Law Program, was inspired by a growing sense that there is a need to reconsider our regulatory…

    Technical illustration of a respirator device
  • Read more: What the Trade War with China Means to the Medical Industry
    Article

    What the Trade War with China Means to the Medical Industry

    By Stephen Wood If you rely on a pacemaker, an implanted defibrillator, a prosthetic hip, wear contacts or need an MRI, then you should be concerned about the constant threat and imposition of tariffs on Chinese imports by the Trump Administration. Using Section 301 of the Trade Act of 1974, President Donald Trump imposed new…

    Medical devices in a doctor's office
  • Read more: Products Liability or Medical Malpractice? The Definition of a “Healthcare Provider”
    Article

    Products Liability or Medical Malpractice? The Definition of a “Healthcare Provider”

    By Alex Stein Every defendant in a suit for medically inflicted injuries wants to be a “healthcare provider.” This status entitles the defendant to categorize the suit as “medical malpractice” and become eligible to special litigation advantages, which include shortened limitations and repose periods, dismissal of suits not verified by experts, and statutory caps on damages….

  • Read more: UDI Adoption: A Necessary Step Towards Better Care for Patients with Implanted Devices
    Article

    UDI Adoption: A Necessary Step Towards Better Care for Patients with Implanted Devices

    By Dalia Deak In the United States, though many millions of individuals live with implanted devices, it may shock you to know that it is easier to recall tainted dog food than it is to recall a faulty pacemaker. This is due in large part to the lag of the medical device world behind most other…

  • Read more: The FDA Strikes Again: Its ban on home testing kits is, as usual, likely to do more harm than good
    Article

    The FDA Strikes Again: Its ban on home testing kits is, as usual, likely to do more harm than good

    By Richard Epstein Cross-post from PointOfLaw. Richard A. Epstein is a professor of law at NYU Law School, a Senior Fellow at the Hoover Institution, a Senior Lecturer at the University of Chicago and a visiting scholar with the Manhattan Institute’s Center for Legal Policy. His forthcoming book is “The Classical Liberal Constitution,” from Harvard…