One of the sessions at this year’s Food and Drug Law Institute’s enforcement conference dealt with the use of AI for FDA compliance activities, but the question of AI legislation also arose. The problem with AI legislation, said Nathan Brown of Akin Gump, is how to manage the details of any legislation, which presents enough drag that federally preemptive legislation stands a faint chance of passage anytime soon.

The U.S. FDA granted accelerated approval for the Biologics License Application for Axogen Inc.'s Avance, an acellular nerve allograft that serves as a scaffold for nerve regrowth, for treatment of patients with sensory, mixed and motor peripheral nerve discontinuities. The company expects Avance to be commercially available in the second quarter of 2026.

Roche AG received regulatory clearance from the U.S. and European authorities for a new diagnostic test that detects Bordetella infections, including whooping cough, as cases surge globally. The point-of-care test, which delivers PCR-accurate results in just 15 minutes, will help health care providers to quickly identify infections and act to prevent severe complications, onward transmission and deaths.

The FDA’s Center for Devices and Radiological Health (CDRH) will have its hands full with the roll-out of the overhauled quality management regulation, but this will have ripple effects on industry as well. Keisha Thomas, associate director for compliance and quality at CDRH, told an audience in Washington DC that risk management will be a big focus in FDA oversight and inspections in 2026, a point of emphasis that could lead to more routine compliance and enforcement action.

The U.S. Centers for Medicare & Medicaid Services has posted the home health final rule for calendar year 2026 and has established a framework for competitive bidding for products such as continuous glucose monitors, a move that is struggling to find support among stakeholders.

The U.K. National Institute for Health and Care Excellence announced an increase in the cost effectiveness thresholds for its health technology assessment program, but this new threshold falls far short of where the figure should be when adjusting for inflation.

Proving its latest addition to the Farapulse pulsed field ablation (PFA) platform is no turkey, Boston Scientific Corp.'s Farapoint PFA catheter received CE mark as the U.S. celebrated Thanksgiving. Farapoint is indicated for ablation of the cavotricuspid isthmus, specifically to treat right atrial flutter.

The Office of Inspector General issued a report stating that the Medicare program could save “tens of millions of dollars” in a single year on continuous glucose monitors and associated supplies if the Centers for Medicare & Medicaid Services acted to apply price pressure on suppliers.

The U.S. Centers for Medicare & Medicaid Services will cover certain cardiac electrophysiology procedures in ambulatory surgical centers in 2026. This change which drew the support of both the Heart Rhythm Society and the American College of Cardiology, which could increase device utilization.