While the U.S. Supreme Court sidelined itself over patent issues such as subject matter eligibility, the diagnostic patent wars are still in full swing as a casual review of cases at the U.S. Patent and Trademark Office discloses.

Australia’s Therapeutic Goods Administration posted a draft guidance dealing with non-mandatory audits for premarket applications, which says that a transcatheter aortic valve replacement device that has been approved by the U.S. FDA may not be subject to such an audit.

False Claims Act litigation in the U.S. spiked significantly according to a new report by Gibson, Dunn & Crutcher, LLP, at least in terms of the number of cases brought to the courts.

The U.K.’s new postmarket monitoring requirements do not represent a sea change in device makers’ responsibilities in this area, but the expansions of responsibility are nonetheless significant.

Murray Hill, N.J.-based C.R. Bard Inc. agreed to pay roughly $17 million to settle allegations that it violated the Anti-Kickback Statute in connection with the use of a self-referral form for sales of the company’s intermittent catheter.

A pair of investor calls on Jan. 22 added clarity to the rapidly evolving cardiac ablation market with Abbott Laboratories and Johnson & Johnson providing updates on their pulsed field ablation programs. Both outlined challenges in the U.S. market that continue to place them at a disadvantage compared to current market leaders Boston Scientific Corp. and Medtronic plc, though bright spots also shone through.

The volume of U.S. FDA warning letters to device makers oscillated significantly in recent years, but the agency posted a handful of these letters to kick off the new year. Five letters were posted Jan. 14, and dated between Dec. 6 and Dec. 19, 2024, but otherwise seem to have little in common.

South Korea’s Ministry of Food and Drug Safety said it released the world’s first guideline on reviewing and approving generative artificial intelligence-based medical devices Jan. 24, to help establish standards on the technology’s applications in the medical field.

With key officials yet to be confirmed at the U.S. Department of Health and Human Services, the acting secretary imposed an immediate pause throughout the department on publicly issuing any document or communication without first getting it approved by a presidential appointee.

The backlog of requests for Medicare national coverage analyses is a matter of record, but a new analysis highlights how deep that backlog runs. CMS declared it will review a petition from Impulse Dynamics to consider coverage of cardiac contractility modulation, responding to a request the company filed more than two and a half years ago.