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.
The Trump administration’s declaration of a new round of tariffs did not sit well with trade associations, but the impact of those tariffs may vary somewhat by company. Analysts said the lack of clarity regarding the impact of tariffs makes it difficult to predict the impact on the device and diagnostics industries, leaving investors and customers alike with a large overhang of uncertainty.
The renal denervation patent wars are now in full swing, with subsidiaries of Medtronic plc and Recor Medical LLC, landing the first blow in this chapter of the med tech patent struggles.
The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) unveiled the pilot version of its AI Airlock in 2024, and the agency posted a list of the products that are taking part in this version of a regulatory sandbox.
The financial collapse of direct-to-consumer genetic testing pioneer 23andme Holding Co. is already one of the more notable developments of 2025, but the company’s customers have less to worry about with regard to their data.
The U.S. FDA famously lost a lawsuit over its final rule for regulation of lab-developed tests (LDTs), but Jeff Shapiro of King & Spalding told BioWorld that the implications of this decision go beyond FDA regulation of clinical lab operations.
Australia’s Therapeutic Goods Administration floated a draft rule on risk classification for in vitro diagnostics, which does not apply to home use tests, the subject of impending rulemaking.
