U.S. Smart Medical Devices Market Size & Outlook
U.S. smart medical devices market, 2018-2030 (US$M)
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U.S. smart medical devices market highlights
- The U.S. smart medical devices market generated a revenue of USD 26,512.8 million in 2024 and is expected to reach USD 54,614.5 million by 2030.
- The U.S. market is expected to grow at a CAGR of 12.9% from 2025 to 2030.
- In terms of segment, therapeutic devices was the largest revenue generating product type in 2024.
- Therapeutic Devices is the most lucrative product type segment registering the fastest growth during the forecast period.
Smart medical devices market data book summary
| Market revenue in 2024 | USD 26,512.8 million |
| Market revenue in 2030 | USD 54,614.5 million |
| Growth rate | 12.9% (CAGR from 2025 to 2030) |
| Largest segment | Therapeutic devices |
| Fastest growing segment | Therapeutic Devices |
| Historical data | 2018 - 2023 |
| Base year | 2024 |
| Forecast period | 2025 - 2030 |
| Quantitative units | Revenue in USD million |
| Market segmentation | Diagnostics and Monitoring Devices, Therapeutic Devices |
| Key market players worldwide | Abbott Laboratories, Medtronic PLC, Roche Holding AG, DexCom Inc, Masimo Corp, Draegerwerk AG & Co KGaA, SmartCardia, Microlife Corp, Beurer, Adherium Ltd, Ascensia Diabetes Care, LifeScan, AgaMatrix, Arkray, i-SENS Inc, ACON Laboratories, Nipro Corp, Garmin Ltd, Fourth Frontier, Nonin Medical, Sensoria, Sonova Holding AG, WS Audiology, Demant A/S |
Other key industry trends
- In terms of revenue, U.S. accounted for 29.3% of the global smart medical devices market in 2024.
- Country-wise, U.S. is expected to lead the global market in terms of revenue in 2030.
- In North America, U.S. smart medical devices market is projected to lead the regional market in terms of revenue in 2030.
- Canada is the fastest growing regional market in North America and is projected to reach USD 9,641.8 million by 2030.
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Smart Medical Devices Market Scope
Smart Medical Devices Market Companies
| Name | Profile | # Employees | HQ | Website |
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U.S. smart medical devices market outlook
The databook is designed to serve as a comprehensive guide to navigating this sector. The databook focuses on market statistics denoted in the form of revenue and y-o-y growth and CAGR across the globe and regions. A detailed competitive and opportunity analyses related to smart medical devices market will help companies and investors design strategic landscapes.
Therapeutic devices was the largest segment with a revenue share of 96.22% in 2024. Horizon Databook has segmented the U.S. smart medical devices market based on diagnostics and monitoring devices, therapeutic devices covering the revenue growth of each sub-segment from 2018 to 2030.
The FDA's medical device regulatory process involves classification based on risk (Class I, II, III), determining the required regulatory controls. Devices must adhere to the Quality System Regulation (QSR) for design, manufacturing, and labeling.
Key regulatory steps include product registration, premarket submissions (510(k), PMA), and compliance with post-market surveillance.
In addition, the FDA provides pathways like de novo and exemptions for certain devices. This framework ensures device safety and effectiveness while promoting innovation.
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Our clientele includes a mix of smart medical devices market companies, investment firms, advisory firms & academic institutions.
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Approximately 65% of our revenue is generated working with competitive intelligence & market intelligence teams of market participants (manufacturers, service providers, etc.).
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Horizon Databook provides a detailed overview of country-level data and insights on the U.S. smart medical devices market , including forecasts for subscribers. This country databook contains high-level insights into U.S. smart medical devices market from 2018 to 2030, including revenue numbers, major trends, and company profiles.
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U.S. smart medical devices market size, by product type, 2018-2030 (US$M)
U.S. Smart Medical Devices Market Outlook Share, 2024 & 2030 (US$M)
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