AdvaMed Urges Congress to Boost MedTech Access
Washington D.C., Tuesday, 4 March 2025.
AdvaMed’s agenda for the 119th Congress aims to reduce the 5.7-year wait for Medicare coverage on FDA-cleared devices, promote AI-enabled medtech, and enhance patient access to pioneering technologies.
Streamlining Medicare Coverage Decisions
The current 5.7-year median wait time for Medicare coverage decisions on FDA-cleared medical technologies presents a significant barrier to patient access [1]. AdvaMed’s newly released agenda, unveiled on March 3, 2025, calls for legislative action through several key bills, including the Supporting Innovation for Seniors Act and the Timely Access to Coverage Decisions Act, aimed at expediting this process [2]. The initiative comes at a crucial time when the U.S. maintains its position as the global leader in medtech, representing 40% of the global market, with two-thirds of medical technologies used in America being manufactured domestically [1].
Advancing AI Integration in Healthcare
With the FDA having authorized more than 1,000 AI-enabled devices, AdvaMed emphasizes the urgent need for policy modernization to match technological advancement [1]. The organization is advocating for updated HIPAA regulations to facilitate the sharing of datasets necessary for AI model development while maintaining patient privacy protections [1]. Scott Whitaker, President and CEO of AdvaMed, describes the current period as potentially evolving from ‘the golden age of medical technology innovation’ into ‘the platinum age’ [3].
Supply Chain Resilience and Global Trade
The agenda addresses critical supply chain concerns, particularly in light of recent trade developments. With medical technology exports averaging approximately $72 billion between 2022 and 2024 [1], AdvaMed is pushing for strategic exemptions from tariffs for essential medical technologies [1]. The organization emphasizes the need for bipartisan legislation similar to the Medical Supply Chain Resiliency Act to ensure robust and sustainable medical supply chains [1].
Regulatory Reform and Innovation Support
Following recent staffing challenges at the FDA, including the layoff of approximately 230-240 employees in February 2025 [6], AdvaMed is advocating for enhanced resources to streamline the medical device review process. The organization is championing the Medical Device Electronic Labeling Act to modernize device information delivery [1]. Additionally, AdvaMed supports maintaining tax policies that encourage investment in small medtech companies, which comprise more than 80% of the industry [3].