The Food and Drug Administration is warning physicians that patients implanted with the nation's only approved dissolvable heart stent may be having more cardiac issues than those with a traditional stent.
Dr. Scott Gottlieb, who has often said red tape hampers competition in the pharmaceutical market, has been nominated to be the nation's top federal regulator of drugs and devices.
More than 3,700 women have filed lawsuits against the company in the U.S., alleging harm from its permanent sterilization device Essure.
The Trump administration has thrown its weight behind giving patients the “right to try” experimental drugs outside clinical trials. While such laws purport to offer hope for the dying, they will actually slow medical progress.
The Food and Drug Administration says St. Jude Medical's Merlin@home Transmitter could be hacked by an unauthorized user, which could lead to rapid battery depletion and inappropriate pacing or shocks to a patient's cardiac device.
Turbulent times always produce winners and losers, and the 2016 elections, MACRA, the 21st Century Cures Act and the general pace of change in the healthcare industry created plenty. Here are just a few.
The 21st Century Cures Act, which overwhelmingly passed the House last week, opens new avenues for companies to win quicker FDA approval. It continues to draw fire from safety advocates and worried payers, who foot the bill for expensive new therapies.
With the fast-tracked reboot of the 21st Century Cures Act, drug and device manufacturers may be about to win long-sought revisions to how the Food and Drug Administration approves and regulates their products.
At first, Vincent Karst, 55, was recovering well from his open-heart surgery in March 2015. He resumed the activities he enjoyed, such as visiting car shows and eating out. But some months later, his condition mysteriously deteriorated.
For patients who want to use newer, novel devices beyond clinical trials, affordability is often the central issue blocking access when insurers won't cover their purchase. Manufacturers that can't get widespread coverage for their products face the prospect of limited sales.
By having their cases heard in state court, the plaintiffs can join a larger, recently coordinated group of cases in California filed against Bayer over harm allegedly caused by its sterilization device Essure.
Teva Pharmaceutical Industries, the Israel-based generic drug giant, will report its financials this week amid uncertainty following the presidential election and increased competition by rival Mylan Pharmaceuticals on a generic EpiPen.