The global market for AI in medical devices reached about US$ 21.50 billion in 2023 and is projected to grow to roughly US$ 228.98 billion by 2031, reflecting a very high compound annual growth rate (CAGR) of 34.7%. Within this, the U.S. market is particularly active: several AI-based medical devices received regulatory approvals in 2025, signaling strong momentum for adoption in hospitals and clinics nationwide.
Recent developments include a “multi‑triage” AI-powered tool from Aidoc, designed to flag a broad range of urgent conditions from abdominal CT scans. This marks a shift toward general-purpose AI diagnostic systems rather than narrow, specialized tools. Additionally, Hyperfine, Inc. won clearance for a portable MRI system (Swoop®) powered by proprietary AI software, broadening access to advanced imaging in clinical and community settings.
The market breakdown shows that roughly 50% of value comes from software, such as AI algorithms for diagnostics, predictive analytics, and workflow optimization; about 25% from hardware, including imaging devices and computing systems; and 25% from services like implementation, maintenance, and integration. Radiology remains the dominant medical specialty for AI applications, but cardiology, oncology, hematology, and orthopedic imaging are emerging prominently as adoption spreads.
Despite these opportunities, experts urge caution. While AI-enabled devices promise faster and more accurate diagnosis along with improved healthcare efficiency, concerns remain regarding safety, transparency, regulatory oversight, and risk reporting — especially as the number of AI/ML-enabled devices cleared by the U.S. Food and Drug Administration continues to grow. The challenge for the medical community and regulators is to harness AI’s potential without compromising patient safety or fairness.
