Report Highlights

Non-Destructive Medical Technologies in the U.S.: Market Overview

The U.S. non-destructive medical technologies market, spanning MRI, CT, digital radiography, diagnostic ultrasound, and endoscopy systems, reached USD 48.6 billion in 2024 and is forecast to reach USD 80.3 billion by 2032. Its structure is shaped by the FDA's Center for Devices and Radiological Health, which classifies these systems, and by the Radiation Control for Health and Safety Act of 1968, which sets performance standards for X-ray and CT emitters. Mammography units fall under the separate Mammography Quality Standards Act of 1992.

Government is the dominant force on the demand side. The Centers for Medicare and Medicaid Services sets Physician Fee Schedule and Hospital Outpatient Prospective Payment System rates that determine which scanners hospitals purchase and how often they replace them. The private sector leads on innovation and manufacturing: GE HealthCare, Siemens Healthineers, and Koninklijke Philips account for most commercial imaging development, while the National Institute of Biomedical Imaging and Bioengineering funds academic research rather than production.

Policy-Driven Growth in U.S. Non-Destructive Imaging

The Medicare Access and CHIP Reauthorization Act of 2015 created the Merit-based Incentive Payment System, which adjusts physician payments by up to nine percent based on quality and resource-use measures. Imaging practices that adopt digital radiography and low-dose CT protocols score higher, so they replace legacy analog equipment to protect payment. This converts a payment rule into a replacement cycle that favors established vendors with dose-tracking platforms.

The One Big Beautiful Bill Act (Public Law 119-21) created a USD 50 billion Rural Health Transformation Program, administered by CMS, which channels state-level grants toward rural hospital capital equipment over fiscal years 2026 to 2030. Separately, Section 3305 of the Consolidated Appropriations Act, 2023 requires cyber devices to include software bills of materials and cybersecurity plans in FDA submissions, forcing hospitals to retire unsupported networked scanners. Both mechanisms convert federal spending and security rules into direct equipment purchases.

Regulatory Barriers and Compliance Costs

Class II imaging systems require a 510(k) premarket notification under the Federal Food, Drug, and Cosmetic Act, with the FDA's review goal set at 90 days under MDUFA V. Novel high-risk systems require a premarket approval application, which carries a user fee exceeding USD 500,000 per original submission and a statutory 180-day review goal. Sponsor response periods routinely extend total clearance timelines well beyond these goals, adding months to launch schedules.

State certificate of need laws, administered by individual state health departments, require approval before an imaging center acquires an MRI or CT scanner, with approval timelines often running six to twelve months. Tariff exposure adds cost: the Department of Commerce's Section 232 investigation into imported medical devices threatens duties on components and finished systems. Compliance with the FDA's Quality Management System Regulation adds further internal cost before any product ships.

Policy-Created Opportunities in the U.S.

CMS's Transitional Coverage for Emerging Technologies pathway, finalized in August 2024, grants provisional Medicare coverage to up to five breakthrough devices annually while evidence accrues. The FDA's Breakthrough Devices Program, established under Section 515B of the Federal Food, Drug, and Cosmetic Act, gives sponsors priority interaction with agency reviewers. Developers of AI-assisted ultrasound and portable MRI can use both pathways to reach reimbursement faster than conventional submissions allow.

The Rural Health Transformation Program creates a procurement window for point-of-care ultrasound and digital radiography in critical access hospitals, where portable equipment avoids the capital cost of dedicated imaging suites. Butterfly Network's handheld ultrasound and Fujifilm's portable digital radiography systems are positioned for this demand. Section 3305 cyber requirements also open a replacement market for vendors offering software bills of materials.

Market at a Glance

Leading Market Participants

• GE HealthCare
• Siemens Healthineers
• Koninklijke Philips
• Canon Medical Systems USA
• Fujifilm Healthcare Americas
• Hologic
• Butterfly Network
• Olympus Corporation of the Americas
• Carestream Health
• United Imaging Healthcare

Regulatory and Policy Environment

The primary legislation is the Federal Food, Drug, and Cosmetic Act, enforced by the FDA's Center for Devices and Radiological Health and supplemented by the Radiation Control for Health and Safety Act of 1968 and the Mammography Quality Standards Act of 1992. Manufacturers must maintain 21 CFR Part 820 quality systems, which transition to the Quality Management System Regulation effective February 2, 2026, incorporating ISO 13485 by reference. Reimbursement compliance runs through CMS under the Medicare Access and CHIP Reauthorization Act of 2015.

Upcoming changes include MDUFA VI negotiations, which must conclude before MDUFA V authority expires on September 30, 2027, and final FDA guidance on AI-enabled device software functions following the January 2025 draft. Compared with peers, the U.S. 510(k) pathway is faster than the European Union's Medical Device Regulation (Regulation (EU) 2017/745), which requires notified-body certification for most Class IIa and higher devices. Health Canada's Medical Devices Regulations (SOR/98-282) offer comparable premarket timelines, but the U.S. framework remains the fastest at national level and the most fragmented at state level.

Long-Term Policy Outlook for U.S. Non-Destructive Diagnostics

By 2032, MDUFA VI will set FDA review goals and fee schedules for the next five fiscal years, and the outcome will determine whether AI-enabled imaging software reaches market faster. Final FDA guidance on AI-enabled device software functions will convert the January 2025 draft into binding expectations for submission content, including lifecycle management plans.

Medicare payment policy will shift toward outcomes-linked reimbursement as MIPS scoring matures under the Medicare Access and CHIP Reauthorization Act of 2015. Section 232 tariff outcomes will decide whether U.S.-manufactured MRI and CT systems from GE HealthCare's Waukesha facility retain pricing advantage against imports from United Imaging Healthcare. Rural Health Transformation disbursements through fiscal 2030 will set the size of the rural replacement market.