AI in Medical Devices Industry - Regional Synopsis
North America Market Analysis
North America in the AI in medical devices market is projected to account for the highest share of 45.6% during the forecast period, with a growth rate of 19.2%. This regional growth is attributed to the existence of a favorable policy structure and the presence of strong healthcare infrastructure. Besides, the U.S. constitutes 94% of the overall regional revenue, which is facilitated by Medicare’s 2025 reimbursement expansion that covers AI diagnostics for 47 million beneficiaries. Meanwhile, Canada generously contributes 14.5% of the regional growth, which is supported by Health Canada’s USD 3.8 billion AI healthcare strategy, all of which is positively impacting the market in the region.
The AI in medical devices market in the U.S. is anticipated to dominate the region, effectively driven by expansion in Medicare reimbursement policies that cover 45.5% of AI diagnostics. Also, there is the provision of federal funding for AI healthcare through research and development that has increased to USD 6.1 billion in 2024, out of which the NIH has allocated 35% to oncology-based AI tools. Besides, Medicaid currently reimburses 13 AI-specific devices and systems, including distant monitoring wearables, that have reduced hospitalizations by almost 25%, thereby creating a prolific opportunity for market expansion in the country.
The AI in medical devices market in Canada is anticipated to expand at a 17.2% growth rate, which is relatively facilitated by USD 3.5 billion federal healthcare and medical AI funding since 2024. Besides, Ontario is one of the leading cities with provincial adoption, which has resulted in covering 9 AI diagnostics under the presence of public insurance, which has further diminished waiting duration by 35%. Meanwhile, the 2024 AI Regulatory Framework of Health Canada has accelerated acceptances, with almost 16 devices receiving clearance in 2023, thus suitable enough for the market to gain increased importance in the country.
Europe Regional Market Size & Growth
Europe in the AI in medical devices market is anticipated to hold a considerable share of 30.5% by the end of 2037, highly fueled by an increase in the aging population and the EU regulatory harmonization. The domestic Health Data Space initiative has provided a fund of €2.7 billion to enhance the AI integration, especially with France and Germany leading in the adoption. Besides, reimbursement modifications, rare disease burden, and administrative tailwinds are other key factors readily driving the market growth in the region. For instance, as per the WHO report, an estimated 42% of the regional population over 65 years of age is readily in demand for AI-driven remote monitoring devices, which is positively impacting the market upliftment.
The AI in medical devices market in Germany is expected to hold 37% of the overall regional revenue by the end of the forecast timeline, owing to an increase in hospital adoption and the presence of robust governmental support. For instance, there has been an allocation of €1.6 billion by the Federal Ministry of Health for its KI-SIG AI initiative that commenced in 2024, thereby accelerating acceptance for almost 80 AI devices under the supervision of the EU MDR. Besides, leading hospital centers such as Charité Berlin have reported 35% of few diagnostic errors with the AI-powered imaging utilization, thereby suitable for the market growth in the country.
The AI in medical devices market in France is expected to hold 27.5% of the overall regional revenue, which is facilitated by €1.2 billion from the France 2030 strategy for AI diagnostics. Besides, the Haute Autorité de Santé (HAS) has mandated 33% of cost savings for reimbursement, which has further pushed the AI adoption in almost 38% of rural clinics in the country. Moreover, domestic start-up organizations such as Owkin have successfully leveraged public-private funding for oncology AI through an increase in device costs that has limited wide accessibility.
