U.S. Software as a Medical Device Market: Key Players &...

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2025-09-02 12:48:22

U.S. Software as a Medical Device Market: Key Players & Industry Outlook

The U.S. Software as a Medical Device (SaMD) market was valued at USD 2.1 billion in 2023 and is projected to reach USD 8.4 billion by 2032, growing at a CAGR of 16.5% (2024–2032). The growth is driven by the rise in AI- and ML-powered healthcare applications, increasing adoption of digital therapeutics (DTx), and a strong regulatory framework from the U.S. FDA supporting innovation in...

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