Bridging the Atlantic: Communicating Europe’s AI-Driven Healthcare Innovations to US Stakeholders

What does it take for a breakthrough AI diagnostic tool developed in France or Sweden to gain traction in Boston or Chicago?

The answer lies not just in its algorithms, but in its ability to strategically communicate within the US healthcare system.

Europe is fast becoming a powerhouse for AI-driven healthcare, with innovations emerging from a mix of startups, university spin-outs, and publicly funded research initiatives. As these technologies mature, many face a familiar hurdle: navigating the commercial and regulatory complexities of the United States—still the world’s largest and most competitive healthcare market. From FDA classifications to fragmented reimbursement structures, the transatlantic journey for European MedTech is marked by both opportunity and nuance.

To succeed, European innovators must go beyond clinical excellence. They need to adapt their strategies to the unique demands of the US landscape—aligning with the expectations of regulators, payers, and procurement leaders through targeted communication, robust evidence generation, and AI-driven market intelligence.

Divergent Landscapes: Regulation and Market Expectations

Europe’s approach to AI in healthcare is shaped by a rigorous, ethics-first framework. The EU AI Act, provisionally adopted in 2024, classifies AI systems by risk and imposes strict obligations on high-risk applications—healthcare among them. These rules work in tandem with the EU Medical Device Regulation (MDR), which governs the clinical evaluation, safety, and performance of medical devices and diagnostic technologies. Together, they form a comprehensive but complex compliance environment that prioritises patient safety and data transparency.

In contrast, the US regulatory environment, anchored by the Food and Drug Administration (FDA), favours a more adaptive, iterative model. The FDA has introduced several regulatory pathways for digital health and AI/ML-based medical devices, including:

• 510(k) premarket notification, which allows manufacturers to demonstrate that their device is substantially equivalent to an already approved product. This is often a faster and less costly route to market.
• De Novo classification, designed for novel devices with no direct predicate, enabling innovators to bring first-of-their-kind technologies to market with a reasonable assurance of safety and effectiveness.
• The Breakthrough Devices Program, which offers expedited review for technologies addressing life-threatening or irreversibly debilitating conditions.

Rather than a single overarching regulation like the EU AI Act, the FDA operates through evolving guidance documents and pilot initiatives, such as the AI/ML Software as a Medical Device (SaMD) Action Plan, which supports innovation while focusing on algorithm transparency, real-world performance monitoring, and adaptive learning systems.

While the FDA’s flexible approach can enable faster market access, its lack of harmonisation presents both opportunity and risk. Therefore, European innovators must reframe their compliance narratives to meet US expectations and present a compelling case for both safety and scalability.

AI-Powered Insights to Guide Market Strategy

The complexity of entering the US healthcare market can be mitigated with AI-driven intelligence that maps demand trends, procurement behaviours, and reimbursement models. With the right tools, innovators can uncover patterns in stakeholder adoption, financial viability, and technology uptake timelines to identify:

• US healthcare systems adopting AI diagnostics or robotic surgical systems.
• Reimbursement pathways established by Medicare and private insurers for AI-powered solutions through new CPT (Current Procedural Terminology) codes—the billing codes used by clinicians and hospitals to report medical procedures and services.
• Opportunities where data from routine clinical practice influences formulary listings and hospital technology assessments.

Unlike Europe’s nationally standardised DRG-based reimbursement systems, the US market is highly fragmented—comprising public and private payers, each with distinct coverage policies. Even clinically approved solutions must undergo rigorous economic value assessments before they gain traction.