Regulatory oversight, innovation, and access in aortic dissection care: The evolving roles of the US Food and Drug Administration and Centers for Medicare & Medicaid Services.

Advances in the management of aortic dissection have been driven by rapid innovation in endovascular technology, improved imaging, and multidisciplinary care models. Critical to translating these innovations into broader clinical practices are the US Food and Drug Administration and the Centers for Medicare & Medicaid Services. These organizations' regulatory and reimbursement policies shape device development, patient safety, and access to care. Although the overall mission of the US Food and Drug Administration and Centers for Medicare & Medicaid Services is to provide a structured evaluation and safe introduction of new technologies, as well as evidence-based adoption as standard of care, these frameworks may also contribute to disparities in access to advanced therapies. This review examines the historical evolution of aortic dissection treatment and generation of clinical evidence through the lens of US Food and Drug Administration and Centers for Medicare & Medicaid Services policy and discusses how complementary, yet fragmented, oversight models influence innovation, outcomes, and equity in contemporary aortic dissection care.