St. Jude is focusing on innovation in the face of softening demand for older devices, and Advamed weighs in on the medical device user fees deal.
St. Jude will start selling minimally invasive aortic heart valves and an ablation device to treat hypertension in Europe by the end of the year, Starks said. Analysts estimate the valve market, now led by Medtronic Inc. and Edwards Lifesciences Corp., exceeds $2 billion a year, while the hypertension market may top $25 billion, St. Paul, Minnesota-based St. Jude said.
The focus on high-profit new products will help St. Jude return to “high single-digit or low double-digit” sales gains for the next five years, Starks said.
The Food and Drug Administration said Wednesday it reached a tentative deal with the medical device industry on user fees. The deal would let the FDA collect more than half a billion dollars from companies over the next five years, double what it got in the last user fee renewal, but in return would agree to a faster, more transparent device review process.
A bill introduced this week would close a loophole that lets devices win approval even when they’re similar to a product already pulled from the market, the Democratic lawmakers, led by Representative Edward Markey of Massachusetts, said in a statement yesterday.
A report from the Government Accountability Office finds that some hospitals pay thousands of dollars more than others for the very same medical device, the WSJ reports. The higher prices could affect Medicare spending, since payments to hospitals are in part based on the institutions’ costs, the paper says.
The European Union says it will propose tougher medical device inspections in the wake of the leaking breast implants scandal.
EU Health Commissioner John Dalli said Thursday that under the proposals "the capacity to detect and minimize the risk of fraud must be increased."