Device Safety

Latest Headlines

Latest Headlines

FDA warns against inappropriate use of fetal ultrasound imaging and heartbeat monitoring

The FDA issued a warning against unnecessary and excessive fetal ultrasound imaging and heartbeat monitoring using Doppler heartbeat monitors, advising women not to receive or perform the procedures at home or for nonmedical reasons.

FDA issues new guidance on MRI safety and compatibility of medical devices

The FDA just issued new guidance on the MRI compatibility--or in some cases incompatibility--of implants that do not require electrical power to service their function, such as cardiovascular stents, intracranial aneurysm clips, endovascular grafts and transprostatic tissue retractors.

Judge advises Bard to settle vaginal mesh implant cases

After recent courtroom losses for Johnson & Johnson and Boston Scientific in cases involving vaginal mesh implants, a federal judge encouraged C.R. Bard to settle the thousands of similar lawsuits it faces. In doing so, he cited the responsibility of the company to its shareholders to limit losses, according to a Bloomberg article.

Physicians weigh in on ventricular assist devices for treating heart failure

As the med tech industry casts its eye toward next-generation devices for severe cardiac conditions, physicians are weighing in on the products' efficacy in treating patients with heart failure.

JAMA study: Cochlear implants can cause pain during MRIs

Some patients with cochlear implants feel pain during an MRI that is strong enough to prevent them from completing the procedure, a recent study in the Journal of the American Medical Association shows.

Boston Scientific ordered to hand over $18.5M in vaginal mesh litigation

Less than a week after Boston Scientific lost its second courtroom battle over vaginal mesh implants, a federal jury ordered the company to pay $18.5 million in damages to four women who claimed the devices caused them constant pain and injuries.

Power morcellation ban unlikely, but other FDA restrictions coming soon

The doctor who brought the cancer risks posed by power morcellation to the attention of the public and the FDA protested what he described as "imminent plans to use legal mechanisms to functionally institute a 'registry of outcomes' or a 'probationary period' in order to avoid banning power morcellators from the marketplace," in an email to Commissioner Hamburg, various U.S. senators, White House officials and others obtained by FierceMedicalDevices.

Dozens of lawsuits filed in growing counterfeit spinal screw implant scandal

More than two dozen lawsuits related to the distribution and use of counterfeit spinal screws and hardware implanted in patients were filed Friday in Los Angeles Superior Court, claiming a former hospital executive and his business partners were in on the conspiracy.

J&J prepares to face ruling in first Pinnacle hip implant trial

Johnson & Johnson is facing grave allegations that the company, in an effort to preserve billions in profit, ignored overwhelming evidence that its Pinnacle hip implants were highly dangerous.

Department of Homeland Security to weigh in on device cybersecurity

Amid growing industry concern over the cybersecurity of medical devices, the U.S. government is weighing in on the issue and investigating two dozen cases of suspected cybersecurity flaws in devices and hospital equipment.