Report Highlights

U.S. Ultrasound Devices: Market Overview

The U.S. ultrasound devices market reached USD 6.4 billion in 2024, the largest national ultrasound market in the world. Cart-based systems still dominate hospital radiology, cardiology and obstetric departments, while handheld and point-of-care units are expanding in physician offices and emergency departments. Federal payment policy has shaped this structure more than any single manufacturer, because Medicare Part B reimbursement sets the economics of every outpatient scan. Government procurement and reimbursement together account for the majority of unit demand.

Private companies lead on device engineering and distribution. GE HealthCare, Philips, Siemens Healthineers and FUJIFILM SonoSite compete on cart platforms and AI-enabled workflow software, while Butterfly Network has built a semiconductor-based handheld line since its 2018 FDA clearance. Government has dominated demand, with Medicare and Medicaid financing most diagnostic volume and the Department of Veterans Affairs buying through national contracts. The Food and Drug Administration sets the entry gate but does not set the price. Policy therefore determines who buys, while manufacturers determine what is bought.

Policy-Driven Growth in U.S. Ultrasound Devices

Three policy mechanisms drive U.S. demand. The Centers for Medicare and Medicaid Services (CMS) annual Physician Fee Schedule, authorized under Section 1848 of the Social Security Act, sets payment for abdominal ultrasound (CPT 76700) and pelvic ultrasound (CPT 76856). Public Law 119-21 created a USD 50 billion Rural Health Transformation Program for fiscal years 2026 through 2030, funding state investment in rural hospital equipment. The CMS Hospital Outpatient Prospective Payment System under 42 CFR Part 419 sets ambulatory payment classification rates for outpatient scans.

Each mechanism converts into unit demand through a different channel. Fee schedule rates determine whether a practice buys a second cart or a handheld probe, because revenue per scan sets the payback period. OPPS rates move procedures into hospital outpatient departments, which favor higher-throughput cart systems. The Rural Health Transformation Program turns federal allocations into capital purchases across more than 1,300 Critical Access Hospitals. Together they sustain replacement cycles through 2032.

Regulatory Barriers and Compliance Costs

Market entry begins with FDA premarket notification under Section 510(k) of the Federal Food, Drug, and Cosmetic Act, with diagnostic ultrasonic pulsed echo imaging systems classified under 21 CFR 892.1550. The Center for Devices and Radiological Health sets a 90-FDA-day review goal under the Medical Device User Fee Amendments, and standard submissions carry user fees above USD 20,000. From February 2, 2026, manufacturers must also comply with the Quality Management System Regulation in 21 CFR Part 820, which aligns quality rules with ISO 13485:2016 and adds audit documentation for every design change.

Commercial and state-level rules add further cost. The Stark Law, 42 U.S.C. 1395nn, and the Anti-Kickback Statute, 42 U.S.C. 1320a-7b(b), restrict physician referral to in-office ultrasound they own, forcing many independent practices to lease equipment. New York's certificate of need requirement under Public Health Law Article 28, administered by the New York State Department of Health, requires state approval before certain imaging equipment is added. Section 524B of the Federal Food, Drug, and Cosmetic Act requires cybersecurity plans and software bills of materials for connected probes, adding documentation cost to each release.

Policy-Created Opportunities in the U.S.

The FDA's final guidance on Predetermined Change Control Plans for AI-enabled device software, issued in December 2024, creates a defined route for ultrasound AI updates without new 510(k) submissions. GE HealthCare's 2023 acquisition of Caption Health demonstrated the commercial value of AI guidance for novice operators, and it set the template for software-led differentiation. Vendors that file PCCPs with initial clearances can ship algorithm improvements on a rolling basis, converting hardware sales into recurring software subscriptions.

The Rural Health Transformation Program opens a direct channel for handheld and portable systems. Critical Access Hospitals with limited capital budgets can use allocations to acquire handheld fleets rather than cart systems that cost several times more per unit. The Department of Veterans Affairs buys ultrasound through the National Acquisition Center in Hines, Illinois, under Federal Supply Schedule contracts, giving vendors that secure FSS listing a standardized federal channel.

Market at a Glance

Leading Market Participants

• GE HealthCare
• Philips Healthcare
• Siemens Healthineers
• FUJIFILM SonoSite
• Canon Medical Systems USA
• Butterfly Network
• Mindray North America
• Esaote North America
• Clarius Mobile Health
• EXO Imaging

Regulatory and Policy Environment

The primary legislation is the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), administered by the FDA's Center for Devices and Radiological Health. Key compliance requirements include Section 510(k) premarket notification, the Quality Management System Regulation in 21 CFR Part 820 effective February 2, 2026, Unique Device Identification under 21 CFR Part 801, medical device reporting under 21 CFR Part 803, and cybersecurity documentation under Section 524B, added by the Consolidated Appropriations Act, 2023. Reimbursement operates under separate Social Security Act authority administered by CMS.

Upcoming changes center on user fee reauthorization. The Medical Device User Fee Amendments (MDUFA V) cover fiscal years 2023 through 2027, so MDUFA VI negotiations must conclude before the September 2027 expiry. Compared with peer jurisdictions, the U.S. 510(k) pathway clears devices faster than the EU Medical Device Regulation (Regulation (EU) 2017/745), where notified bodies control review timing and transition deadlines were extended to 2027 and 2028 under Regulation (EU) 2023/607. Canada's Medical Devices Regulations (SOR/98-282) apply a similar risk-class structure through Health Canada but require a Medical Device Licence for Class II devices.

Long-Term Policy Outlook for Ultrasound Devices in the U.S.

By 2032, three policy shifts will reshape the market. Medicare payment reform will keep tightening office-based ultrasound economics, as CMS applies efficiency adjustments to non-time-based services in annual Physician Fee Schedule rules, reducing per-scan margins for independent imaging practices. Congress must reauthorize the Medical Device User Fee Amendments before September 2027, and MDUFA VI commitments will determine FDA review resources for AI-enabled probes through 2032.

The Rural Health Transformation Program ends after fiscal year 2030, creating a funding cliff that will force rural hospitals to justify equipment replacement under standard Medicare Part B and OPPS economics by 2031. Section 524B cybersecurity enforcement will raise the bar for connected probes, favoring vendors with established security operations. Handheld vendors that secure PCCP-backed clearances early will lock in installed base before those rules tighten, leaving the market concentrated among roughly six platform owners by 2032.