The U.S. FDA announced a class I recall declared by Baxter Healthcare Corp., of Deerfield, Ill., for the automated compounding inlets used with the company’s Exactomix compounding systems due to the risk of particulate matter in the inlets.

The U.S. Court of Appeals for the Federal Circuit remanded a patent case to district court after finding that a patent applicant need not invoke identical terminology when describing a central feature of a catheter technology across multiple patents.

The U.K. National Institute for Health and Care Excellence reported that mental health professionals experienced a dramatic increase in referrals for anxiety and depression over the past decade but noted that digital therapies might help manage the caseload, representing a significant opportunity for developers of these products.

Michelle Tarver, the acting director of the U.S. FDA’s device center appeared on a Sept. 24 webinar to discuss her priorities for the agency going forward, one of which is global health equity.

The U.S. FDA wrapped up the pilot version of the Accreditation Scheme for Conformity Assessment (ASCA) and reported the formation of a permanent ASCA program, which has been seven years in the making.

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.