Medical Devices

New Study Confirms Robotic Surgery Fails to Live Up to the Hype

Hospitals, doctors, and device makers frequently tout the benefits of robotic surgery. However, a new study highlights that it may be more costly and lead to more complications when compared to traditional, low-tech methods. The number of robotic surgeries has skyrocketed in recent years, accounting for...

FDA Seeking to Shut Down Medical Device Company Over Patient Infections

Federal regulators are working to shut down a medical device company that produced ultrasound, mammography, and electrocardiogram gels that have been tied to at least 16 infections. Working with the Department of Justice, the U.S. Food and Drug Administration (FDA) is seeking a permanent injunction against Pharmaceutical...

Jury Awards $73 Million in Transvaginal Mesh Suit

A Texas jury recently awarded $73 million in damages in a lawsuit against Boston Scientific involving a transvaginal mesh device. The jury verdict included $50 million in punitive damages after finding the company was grossly negligent in the design and marketing of its Obtryx sling. According...

FDA Taking Steps to Improve Cybersecurity of Medical Devices

The U.S. Food and Drug Administration (FDA) recently announced that it is moving forward on efforts to strengthen the cybersecurity of medical devices. While pacemakers, defibrillators, and insulin pumps seem like unlikely targets for hackers, a security breach could have drastic consequences. According to the FDA,...

FDA Expanding Oversight of Certain Diagnostic Tests

The U.S. Food and Drug Administration (FDA) recently announced that it is taking steps to increase its oversight over certain diagnostic tests used to help diagnose and treat patients. Under the agency’s current regulatory framework, many laboratory developed tests (LDTs), which are designed, manufactured and intended...

NJ Judge Confirms $11 Million Jury Award in Vaginal Mesh Lawsuit

A New Jersey judge has confirmed an $11 million jury award against Johnson & Johnson in one of the first vaginal mesh lawsuits to proceed to trial. Plaintiff Linda Gross was implanted Gynecare Prolift to treat pelvic prolapse. She suffered significant complications, resulting in severe pain...

Children’s Medical Products: Reporting Problems to the FDA

When your child is sick, getting the right medication or medical device can make all the difference to your child's health. Sometimes, however, medication or a medical device doesn't work the way it's supposed to, and your child may suffer from adverse side effects or...

Urgent Medical Device Correction for the Gemstar™ Docking Station

Are you receiving treatment for a personal injury and currently using a medication delivery system at home to help you manage your pain medication or other medications? If the medication delivery device you are using is the GemStar™ Phase 3 or Phase 4 infusion pump...

Has Your Child’s Medical Device Been Tested To Be Safe for Children?

A much-needed medical device can make a big difference in your child’s life, but one important question parents and pediatricians may need to ask is whether a medical device has been specifically approved for use by children. As reported by U.S. News & World Report, a...

Recall Bolsters Concerns Over da Vinci Robotic Surgery System

The da Vinci robotic surgery system is used in an estimated 350,000 surgeries across the United States every year, including prostate surgery, gallbladder removal, and hysterectomies. Yet concerns over its safety continue to mount. Most recently, Intuitive Surgical Inc., the maker of the robotic surgery system,...

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