November 12, 2026, 5pm London UK
Chair: Howard Loree, PhD
Discussants:
This panel discussion will look back on ten years after the 21st Century Cures Act was enacted by the U.S. Congress and ask whether the promised “modernization” of medical device regulation has delivered on its commitments to patients.
Drawing on the experience of experts in industry, real-world evidence strategy, Medicare coverage policy, and critical‑care device development, the event will explore how the Cures Act reshaped the evidentiary bar for high‑risk devices, enabled the expansion of the FDA’s Breakthrough Devices Program, and altered Medicare’s default stance on coverage and payment. The discussion will also consider the downstream consequences for patient safety and post‑market learning, including emerging concerns about device recalls in technologies benefiting from expedited pathways.
Speakers will examine three interconnected themes: (1) how expedited regulatory pathways and the use of real‑world evidence have changed what counts as “sufficient” data for market entry; (2) how coverage mechanisms (local coverage determinations, coding decisions, and the handling of Category III CPT codes) translate statutory language into real‑world access or de‑facto restriction; and (3) what early signals on safety, recalls, and inequitable adoption imply for patients who are most exposed to under‑evidenced technologies. The seminar will discuss strategies for reforming device regulation and reimbursement to better align incentives with robust evidence generation, transparency, and health equity.
Video