Azon Medical LLC, a supplier of medical products such as durable medical equipment, is on the hook for slightly more than $1 million for promoting the P-Stim device as eligible for Medicare coverage.

The draft Medicare physician fee schedule for calendar year 2025 provoked a strong backlash from physician societies due to a net cut in physician pay. Device makers have their own concerns, including the latest in a series of controversies over coverage of skin substitutes.

The U.S. CMS believes it has a quandary on its hands with regard to transitional pass-through payment for renal denervation devices, but the Medical Device Manufacturers Association urged the agency to provide separate payment mechanisms for these devices as seen in the inpatient final rule.

Artificial intelligence is beginning to make its way into the world of medical device design, but Gregg Van Citters, senior consultant at Medicept, told BioWorld that there are both opportunities and tripwires on the road ahead.

The U.S. Department of Health and Human Services reported the winners of the Leading Edge Acceleration Projects in Health Information Technology program, with a couple of key areas of interest.

The U.S. FDA’s draft guidance for predetermined change control protocols (PCCPs) is out for comment, but a recent agency webinar highlighted some areas of ambiguity.

The U.S. FDA reported Sept. 17 that the Zimmer Biomet Holdings Inc. CPT hip system is associated with an increased risk of thighbone fracture, a problem Zimmer acknowledged with a July 2, 2024, class II recall.

The Nov. 20-21 meeting of the digital health advisory committee will discuss the use of generative artificial intelligence algorithms in medical devices with a focus on the total product life cycle – a theme that suggests a concern on the agency’s part regarding the reliability of these algorithms’ output.

Hiiti Sillo, director of the WHO’s office for regulation and safety, told an audience at this year’s IMDRF meeting in Seattle that WHO is putting the finishing touches on a streamlined product application dossier process, one of several work products that should be ready for publication sometime in 2025.

The U.S. Department of Justice reported that THD America Inc., and its Italian corporate parent company agreed to pay $700,000 over inducing physicians to use incorrect payment codes in Medicare and Medicaid claims.