The Software as a Medical Device (SaMD) market in the United States is projected to experience significant growth, reaching an estimated USD 29.80 billion by 2033, up from USD 6.26 billion in 2025. This expansion is driven by the increasing demand for digital therapeutics and AI-enabled healthcare solutions.
The market is expected to grow at a compound annual growth rate (CAGR) of 20.6% from 2026 to 2033. Key factors contributing to this growth include the rising adoption of software solutions by healthcare providers and regulatory bodies aimed at improving diagnostics, patient monitoring, and clinical decision-making. The trend towards personalized treatment and remote patient monitoring is further fueling the demand for SaMD solutions in both developed and emerging markets.
Notable developments include the FDA's initiatives to streamline the regulatory process for digital health devices, such as the launch of the Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot, which promotes innovative SaMD solutions. Additionally, strategic partnerships, like that between Samsung Electronics and Alcedis, aim to enhance decentralized clinical research through wearable technologies.
This burgeoning market presents opportunities for companies that focus on AI-powered, interoperable, and scalable SaMD solutions. As digital health continues to evolve, stakeholders who invest in advanced technologies and foster strategic collaborations are likely to gain a competitive edge, shaping the future of healthcare delivery.