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.
Sources say President-elect Donald Trump's transition team for HHS will be led by Andrew Bremberg, who worked at the agency under President George W. Bush and was an adviser to Senate Majority Leader Mitch McConnell and during Wisconsin Gov. Scott Walker's presidential bid.
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.
Today's elections surely won't end the eight-year political war over the shape of the U.S. healthcare system. But the ballot results likely will determine whether the changes driven by the ACA continue in the same direction or the system returns to its previous, less-regulated form.
The Food and Drug Administration is considering dramatic changes to its drug marketing rules that threaten to make the problem of already out-of-control drug spending even worse.
There are many reasons for the nation's rising prescription drug spending, which increased 6.3% from August 2015 to August 2016. But you wouldn't think one of them would be that the federal government is actively encouraging drug companies to slap higher price tags on old, cheap products.