Kyle Faget Assesses Regulatory Shifts Impacting Medtech

Foley & Lardner LLP partner Kyle Faget is featured in four Medtech Insight articles evaluating the medtech industry’s major developments in 2025 and examining 2026 regulatory challenges.

In the article, “Last Year Brought Technical Advances Alongside Regulatory Challenges,” Faget identified the removal of certain regulatory barriers as a high point in 2025, specifically referencing the U.S. Food and Drug Administration’s (FDA) decision to step back from regulating lab-developed tests (LDTs). One low point, she shared, was the imposition of tariffs which lead to increased production costs for devices.

Faget assessed the FDA’s approach to regulating health care advertising in the article, “Complexity, Bottlenecks And Cybersecurity Among Key Regulatory Concerns.”

The current administration, she said, “seems uniquely interested in curbing direct-to-consumer advertising and promotion of, primarily, pharmaceuticals, but with consequences for restricted medical devices too.”

In “AI Shows Patient Care Potential, But Regulation Remains Tricky,” Faget said state and federal approaches to regulating AI will shape how rapidly the technology is commercialized. The question, Faget highlighted, “will be whether FDA is impermissibly regulating the practice of medicine.”

Looking ahead, in “Collaboration, Coverage Improvements Top Industry Wish Lists,” Faget said one of her hopes for this year is for the Centers for Medicare & Medicaid Services to “authorize reimbursement quicker for innovative products that are changing care delivery.”