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(SaMD) software as a medical device refers to software intended to be used for medical purposes without being part of a hardware medical device. SaMD can perform a wide range of functions, from providing information for clinical decision-making to directly diagnosing or treating medical conditions.

The (SaMD) software as medical device market consists of sales of (SaMD) software as a medical device by entities (organizations, partnerships and sole proprietors) that develop healthcare software that can help with diagnosis, management and treatment of medical conditions. It can automate some aspects of care, improve quality and save time.

The global (SaMD) software as a medical device market was valued at $8,058.3 million in 2018 which grew till 2023 at a compound annual growth rate (CAGR) of more than 24.0%

Increased Demand For Remote Monitoring In Healthcare

Increased demand for remote monitoring in healthcare services drove the growth of the (SaMD) software as a medical device market during the historic period. Remote monitoring in healthcare refers to the use of technology to monitor patients' health status and vital signs outside of traditional clinical settings, such as hospitals or clinics. SaMD platforms serve as the backbone of remote patient monitoring (RPM) programs, aggregating and analyzing patient-generated health data (PGHD) from various sources, such as wearable devices, smart sensors and mobile health apps. These platforms offer data analytics, trend analysis and predictive modeling capabilities to identify potential health issues, trigger alerts and facilitate clinical decision-making in real-time. According to the American Medical Association's (US-based professional association) Digital Health Research Survey of 1,300 physicians to investigate physician motivations and requirements for integrating remote health tools into their practices, the use of remote monitoring devices more than doubled from 12% in 2016 to 30% in 2022. Therefore, increased demand for remote monitoring in healthcare services supported the growth of the (SaMD) software as a medical device market.

Introduction Of Advanced Software With Improved Analysis Capabilities

Companies operating in the (SaMD) software as a medical device market are increasing their focus on introducing advanced software with improved analysis capabilities to gain a competitive edge in the market. For example, in September 2023, HoneyNaps Co., Ltd., a South Korea-based software company, received approval from the United States Food and Drug Administration (USFDA) for SOMNUM software. It uses deep learning-based AI to perform real-time analysis of various sleep biosignals, including electroencephalograms, electrooculograms, electromyograms, electrocardiograms, respiratory airflow and effort and oxygen saturation. The software is designed to provide more accurate and sophisticated readings than conventional methods and it can shorten the analysis of patient sleep data to under five minutes.

The global (SaMD) software as a medical device market is fairly fragmented, with a large number of players operating in the market. The top ten competitors in the market made up to 25.2% of the total market in 2022.

(SaMD) Software as a Medical Device Market Opportunities And Strategies To 2033 from The Business Research Company provides the strategists; marketers and senior management with the critical information they need to assess the global (SaMD) software as a medical device market as it emerges from the COVID-19 shut down.

Reasons to Purchase

Where is the largest and fastest-growing market for (SaMD) software as a medical device? How does the market relate to the overall economy; demography and other similar markets? What forces will shape the market going forward? The (SaMD) software as a medical device market global report from The Business Research Company answers all these questions and many more.

The report covers market characteristics; size and growth; segmentation; regional and country breakdowns; competitive landscape; market shares; trends and strategies for this market. It traces the market's history and forecasts market growth by geography. It places the market within the context of the wider (SaMD) software as a medical device market; and compares it with other markets.

The report covers the following chapters

Scope

Markets Covered:

Table of Contents

1 Executive Summary

2 Table Of Contents

3 List Of Tables

4 List Of Figures

5 Report Structure

6 Market Characteristics

7 Major Market Trends

8 (SaMD) Software As A Medical Device Market - Macro-Economic Scenario

9 Global Market Size and Growth

10 Global (SaMD) Software As A Medical Device Market Segmentation

11 (SaMD) Software As A Medical Device Market, Regional and Country Analysis

12 Asia-Pacific Market

13 Western Europe Market

14 Eastern Europe Market

15 North America Market

16 South America Market

17 Middle East Market

18 Africa Market

19 Competitive Landscape and Company Profiles

20 (SaMD) Software As A Medical Device Market Other Major And Innovative Companies

21 Competitive Benchmarking

22 Competitive Dashboard

23 Key Mergers And Acquisitions

24 Opportunities And Strategies

25 (SaMD) Software As A Medical Device Market, Conclusions And Recommendations

26 Appendix

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