December 18, 2025

From fiscal years 2020 through 2024, nearly 3,900 medical devices were recalled, yet the FDA was unable to meet its goal of terminating recalls within three months, largely due to staffing and resource limitations. Unlike drug or biologic recalls, device recalls often involve greater complexity and require extensive follow-up, including reviews of manufacturer recall status reports and in-person audit checks. While the FDA has acknowledged these staffing challenges, it currently lacks data on the number and types of personnel needed to effectively oversee and resolve recalls in a timely manner.

Stakeholder feedback to the FDA reflects differing views on how to monitor the real-world performance of AI-enabled medical devices. Industry groups favor a risk-based approach that relies on existing regulatory and quality frameworks, cautioning against new, universal postmarket requirements. Healthcare providers and patient advocates, meanwhile, support ongoing monitoring but say responsibility should largely rest with manufacturers, citing limited hospital resources and the opaque nature of many AI systems. Patients argue that FDA approval should start, not end accountability as AI systems evolve.

Senators voted 51–48 to advance a Republican health care proposal that would expand health savings accounts (HSAs) in lieu of extending enhanced ACA subsidies. In a separate vote, senators also voted 51–48 on a Democratic plan to extend the enhanced subsidies for an additional three years. Both measures failed to reach the 60 votes required to advance, making it likely that the enhanced ACA subsidies will expire at the end of the year.

Optum’s split from Humana in the state of Washington appears to be pushing seniors into plans with Optum’s corporate parent: UnitedHealthcare. This is raising concerns that UnitedHealth’s ownership of both doctors and insurance is being used to disadvantage competitors.

The rule also updated the Consumer Assessment of Healthcare Providers and Systems Home Health Care Survey (HHCAHPS). Medication questions were decreased to two, the COVID-19 vaccination assessment was removed, and three new questions were added.