The new technology add-on payment for the TAG thoracic branch endoprosthesis is likely coming to an end, but the device’s manufacturer, Gore Medical Inc., petitioned CMS to reassign the procedure to a new diagnostic-related group that would more accurately reflect the costs of the related procedure.
The thicket of state-based privacy regulation in the U.S. grows thicker by the day, but Congress seems poised to step in with a bipartisan group that may propose legislation that preempts privacy law.
The Trump administration applied a 90-day hold on nation-specific tariffs, but a group of 26 House Democrats urged the administration to think carefully before acting on a threat to impose tariffs on pharmaceuticals.
Some say it’s not what you say but how you say it, but the U.S. FDA’s Feb. 10, 2025, warning letter to Denver-based Exer Labs Inc., makes clear that a 510(k)-exempt device can’t be altered and promoted for claims that are disallowed under the regulation.
The EU’s Medical Devices Coordination Group (MDCG) issued another revision of its guidance for risk classification for in vitro diagnostics — the fourth such rewrite of a guidance that came out in 2020.
The April 8 Senate hearing on the Trump administration’s tariffs generated some heated debate, although U.S. Trade Representative Jamieson Greer parried some of the criticism by pointing to the yawing trade deficit.
The U.S. NIH published the results of a study of the use of AI in referring patients for intervention for risk of opioid use disorder, which found the algorithm helped stave off hospital admissions.
The U.S. Centers for Medicare & Medicaid Services (CMS) issued a draft coverage memo for transcatheter edge-to-edge repair for the tricuspid valve (T-TEER), which is a development that promises accelerated competition for this anatomical space.
Diopsys Inc. agreed to pay $14.25 million to settle allegations it violated the False Claims Act (FCA) in encouraging the unnecessary use of the company’s Nova device for retinal testing.
Mehmet Oz won the U.S. Senate’s nod as the administrator of the Centers for Medicare & Medicaid Services. Oz brought in 53 aye votes to 45 nays in the Senate’s April 3 confirmation tally, and inherits a complicated task as the Medicare breakthrough devices coverage program continues to face substantial challenges.
