Global Software as a Medical Device (SaMD) Market Growth (Status and Outlook) 2025-2031

Global Software as a Medical Device (SaMD) Market Growth (Status and Outlook) 2025-2031

The global Software as a Medical Device (SaMD) market size is predicted to grow from US$ 1803 million in 2025 to US$ 6222 million in 2031; it is expected to grow at a CAGR of 22.9% from 2025 to 2031.

SaMD is software that performs one or more medical functions. While the software may be embedded in a piece of hardware (as is often the case) it's the software itself that performs the medical function. The international medical device regulators forum (IMDRF), of which the US FDA is a member, describes SaMD as software that may work on general-purpose (non-medical) computing platforms; may be used in combination with other products including medical devices; and may interface with other medical devices or other general-purpose hardware and software that provide input to SaMD.

Global key players of Software as a Medical Device (SaMD) include MindMaze, Medtronic, iSchemaView, Viz.AI., Arterys, etc. The top five players hold a share about 18%.

LPI (LP Information)' newest research report, the “Software as a Medical Device (SaMD) Industry Forecast” looks at past sales and reviews total world Software as a Medical Device (SaMD) sales in 2024, providing a comprehensive analysis by region and market sector of projected Software as a Medical Device (SaMD) sales for 2025 through 2031. With Software as a Medical Device (SaMD) sales broken down by region, market sector and sub-sector, this report provides a detailed analysis in US$ millions of the world Software as a Medical Device (SaMD) industry.

This Insight Report provides a comprehensive analysis of the global Software as a Medical Device (SaMD) landscape and highlights key trends related to product segmentation, company formation, revenue, and market share, latest development, and M&A activity. This report also analyses the strategies of leading global companies with a focus on Software as a Medical Device (SaMD) portfolios and capabilities, market entry strategies, market positions, and geographic footprints, to better understand these firms’ unique position in an accelerating global Software as a Medical Device (SaMD) market.

This Insight Report evaluates the key market trends, drivers, and affecting factors shaping the global outlook for Software as a Medical Device (SaMD) and breaks down the forecast by Type, by Application, geography, and market size to highlight emerging pockets of opportunity. With a transparent methodology based on hundreds of bottom-up qualitative and quantitative market inputs, this study forecast offers a highly nuanced view of the current state and future trajectory in the global Software as a Medical Device (SaMD).

This report presents a comprehensive overview, market shares, and growth opportunities of Software as a Medical Device (SaMD) market by product type, application, key players and key regions and countries.

Segmentation by Type:
Cloud-based
On Premise

Segmentation by Application:
Screening and Diagnosis
Monitoring and Alerting
Chronic Disease Management
Other

This report also splits the market by region:
Americas
United States
Canada
Mexico
Brazil
APAC
China
Japan
Korea
Southeast Asia
India
Australia
Europe
Germany
France
UK
Italy
Russia
Middle East & Africa
Egypt
South Africa
Israel
Turkey
GCC Countries

The below companies that are profiled have been selected based on inputs gathered from primary experts and analyzing the company's coverage, product portfolio, its market penetration.
MindMaze
Medtronic
iSchemaView
Viz.AI.
Arterys
Digital Diagnostics
Siemens Healthcare
Allscripts
Adherium

Please note: The report will take approximately 2 business days to prepare and deliver.