Global Software as a Medical Devices Market - 2024 -2031

October 2025 | 180 pages | ID: GB37371E9089EN
DataM Intelligence

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Software as a Medical Devices (SaMD) Market is segmented By Device Type ( Wearable Device, PCs/Laptop, Smartphone/tablets), By Application ( Diagnostic, Clinical Management), By Deployment Method ( Cloud-based, On-Premise), By Region (North America, Europe, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2024-2031

Report Overview

Software as a medical devices (SaMD) market is estimated to reach at a CAGR of 69.31% during the forecast period (2024-2031).

The term Software as a Medical Device External Link Disclaimer is defined by the International Medical Device Regulators Forum (IMDRF) as 'software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device'

Market Dynamics

The software as a medical devices market growth is driven by the rapid product launches and rising adoption of the Internet of Things (IoT) and connected devices in the healthcare sector. Moreover, ease in regulations for the certification of the SaMD will further boost the market. Additionally, rising investments by the companies for SaMD will allow market players to flourish during the forecast period.

The rising adoption of the Internet of Things (IoT) in the healthcare sector, is expected to drive growth in the forecast period

The increasing adoption of IoT in the healthcare sector is expected to significantly influence the growth of the Software as a Medical Device market over the coming years. Various smart devices, such as sensors, smartphones, and wearables, collect necessary data from the devices, further utilized to enhance customers’ experience. The increasing need for data analysis and analytics integration is expected to propel the Internet of Things market utilization over the forecast period. Some IoT applications in healthcare include continuous monitoring of the blood pressure, heartbeat, body temperature, respiration rate, continuous collection of certain parameters in case of chronic illnesses, and providing remote assistance, among other applications. For instance, in 2018, the FDA approved the electroCore, Inc gammaCore Sapphire hand-held device for the acute treatment of migraine pain in 2020 for the preventive treatment of migraine.

Moreover, in February 2020, Cisco announced enhancements to its IoT portfolio that enable service provider partners to optimize cellular IoT environments and new 5G use-cases. New wireless technologies such as 5G, Wi-Fi 6 – would lead to more devices, and new IIoT use cases give service providers the tools to create competitive cellular IoT offerings for their customers.

Lack of data privacy of patients is likely to hamper the market growth

The privacy of the patient's health data, such as their details, confidential information, family history, sensitive medical history, etc., may be at stake as a data breach is highly prevalent in the industry. There are no stringent laws for data privacy, making the users apprehensive about adopting the software as a medical device technology. This may, in turn, hamper the overall growth of the market during the forecast period.

COVID-19 Impact Analysis

The Covid-19 pandemic resulted in a huge shortage of vacant beds in hospitals worldwide. The patients suffering from chronic illness were advised against visiting hospitals physically for treatment due to the fear of being infected. This trend encouraged the aggressive use of software as a medical device across the globe to ensure no patient suffers due to a shortage of healthcare infrastructure. Thus, the pandemic greatly accelerated the growth of the software as a medical device market.

Market Segment Analysis

The diagnostic segment is expected to hold the largest share in this market segment

The diagnostic segment accounts for the largest market share, owing to the uncertain risk of heart stroke with a sedentary lifestyle that has offered demand for wearable medical devices. Along with increasing disease prevalence, advancements in cardiac disease diagnosis and management have provided immense growth opportunities. Healthcare professionals are also adopting wearable technologies to remotely monitor patients’ heart health and offer on-time treatment with early abnormalities. Additionally, developing novel devices, including patches and wearable defibrillators, allows continuous cardiac activities and critical care tracking. For instance, a wearable necklace ECG monitor has been developed to detect abnormal heart rhythm called atrial fibrillation.

Moreover, vital sign devices are wearable devices that can continuously collect vital signs such as body temperature, blood pressure and heart rate over an extended period. While these wearable monitoring devices cannot transmit data to receivers, healthcare professionals can analyze the collected biometric data for treatment effectiveness; hence wearable vital sign monitors are primarily used in hospitals. The wearable type monitor includes a flexible thermometer strip, an inflatable bladder on a wearable cuff, or a pulse oximeter sensor that measures the patient’s oxygen levels by focusing on skin colour changes.

The cloud-based segment is expected to hold the largest share in this market segment

Cloud-based SaMD is expected to hold a significant share due to the rising popularity and greater functionality and scope compared to on-premise-based devices. It is also anticipated to show multiple growth opportunities in the coming years owing to the rising penetration of IoT in healthcare. For instance, In June 2019, Zoll Medical launched Zoll HFAMS, a patch-based wearable heart management system. Moreover, cloud-based software also allows for high performance on lower-tier hardware, which many healthcare technology giants are taking advantage of to develop high-performance devices through innovations and their research and development. For instance, Singapore-based Biofourmis recently received FDA clearance for its cloud-based AI software RhythmAnalytics, a part of its digital therapeutics program.

The wearable devices segment is expected to hold the largest share in this market segment

Wearable technology, an emerging trend, integrates electronics into daily activities and addresses the changing lifestyles with the ability to be worn on any part of the body. Wearables have gained significant traction, owing to the boom in the fitness trend across consumers. According to Cisco Systems, the number of connected wearable devices is expected to increase from 593 million in 2018 to 1,105 million in 2022. The smartwatch category is experiencing a rise, owing to additional features, like the brand that suits the everyday lifestyle. For instance, Embrace2 of Empatica is the first wrist-worn wearable in the field of epilepsy to be cleared as a medical device for detecting patterns that may be associated with convulsive seizures in children & adults. In September 2020, Apple announced the launch of the Apple Watch Series 6 equipped with revolutionary blood oxygen allowing users to track accurate details of overall wellness. This has broadened its portfolio as well as contributed to the company’s revenue growth.

Market Geographical Analysis

North America region holds the largest market share of global software as a medical device's market

North America is projected to hold the largest market share owing to several companies are getting FDA clearances for their software coupled with the burgeoning investment in the healthcare industry by major countries such as the U.S. and Canada. For instance, in July 2020, Channel Medsystems has announced that it had obtained FDA clearance for its next-generation Cerenecryotherapy product to treat menstrual bleeding. In addition, in May 2020, Arterys Inc. raised $28 million to accelerate the delivery of artificial medical intelligence to practices worldwide. In the latest round of Series C investment, they received the seventh USA FDA clearance from a syndicate led by Benslie Investment Group and Temasek Holdings, with participation by Fosun, Revelation Partners, Emergent Medical Partners and Varian Medical Systems.

Market Competitive Landscape

Software as a medical device market is highly competitive with the presence of global companies. Some of the key players which are contributing to the growth of the market include Arterys Inc., Paragon Biosciences (Qlarity Imaging LLC), Viz.ai, Inc., VitalConnect., Apple, Inc., iSchemaView, inc. (RAPID), IDx Technologies Inc., MaxQ AI, Ltd. Greenfinch Technology, Siemens Healthineers AG, and Koninklijke Philips N.V. The major players are adopting several growth strategies such as product launches, acquisitions, and collaborations, which are contributing to the growth of the software as a medical device globally. For Instance, In December 2020 MaxQ AI, Ltd. launched a second-generation ACCIPIO clinical platform for the healthcare industry to enhance physicians to provide “smarter care” with enhanced clinical workflow.

Market Key Companies to Watch

Paragon Biosciences

Overview: Qlarity Imaging is a portfolio company of Paragon Biosciences. Paragon Biosciences is a global life science leader that creates, builds, and funds innovative biology-based companies in three key areas: cell and gene therapy, adaptive biology, and advanced biotechnology. The company’s current portfolio includes Castle Creek Biosciences, CiRC Biosciences, Emalex Biosciences, Evozyne, Harmony Biosciences, Qlarity Imaging, Skyline Biosciences, and a consistent flow of incubating companies created and supported by the replicable Paragon Innovation Capital model.

Product Portfolio: Qlarity Imaging assists radiologists in diagnosing breast abnormalities with AI-driven technology. QuantX is the first FDA-cleared computer-aided diagnosis software and helps improve radiologist performance during breast MRI interpretation.

Key Developments: On August 2, 2021, Qlarity Imaging and Blackford partnered to bring QuantX Diagnostic AI to more breast radiologists via Blackford Platform to help more patients in need.
1. METHODOLOGY AND SCOPE

1.1. Research Methodology
1.2. Research Objective and Scope of the Report

2. MARKET DEFINITION AND OVERVIEW

3. EXECUTIVE SUMMARY

3.1. Market Snippet by Device Type
3.2. Market Snippet by Deployment Method
3.3. Market Snippet by Application
3.4. Market Snippet by Region

4. MARKET DYNAMICS

4.1. Market Impacting Factors
  4.1.1. Drivers
    4.1.1.1. Rising adoption of the Internet of Things (IoT) in the healthcare sector
  4.1.2. Restraints:
    4.1.2.1. Lack of data privacy of patient’s
  4.1.3. Opportunity
  4.1.4. Impact Analysis

5. INDUSTRY ANALYSIS

5.1. Porter's Five Forces Analysis
5.2. PEST Analysis
5.3. Supply Chain Analysis
5.4. Pricing Analysis
5.5. Regulatory Analysis
5.6. Reimbursement Analysis
5.7. Unmet Needs

6. COVID-19 ANALYSIS

6.1. Analysis of Covid-19 on the Market
  6.1.1. Before COVID-19 Market Scenario
  6.1.2. Present COVID-19 Market Scenario
  6.1.3. After COVID-19 or Future Scenario
6.2. Pricing Dynamics Amid Covid-19
6.3. Demand-Supply Spectrum
6.4. Government Initiatives Related to the Market During Pandemic
6.5. Manufacturers Strategic Initiatives
6.6. Conclusion

7. BY DEVICE TYPE

7.1. Introduction
  7.1.1. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Device Type
  7.1.2. Market Attractiveness Index, By Device Type
7.2. Wearable Device*
  7.2.1. Introduction
  7.2.2. Market Size Analysis, US$ Million, 2018-2028 and Y-o-Y Growth Analysis (%), 2020-2028
7.3. PCs/Laptop
7.4. Smartphone/tablets

8. BY APPLICATION

8.1. Introduction
  8.1.1. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
  8.1.2. Market Attractiveness Index, By Application
8.2. Diagnostic*
  8.2.1. Introduction
  8.2.2. Market Size Analysis, US$ Million, 2018-2028 and Y-o-Y Growth Analysis (%), 2020-2028
8.3. Clinical Management

9. BY DEPLOYMENT METHOD

9.1. Introduction
  9.1.1. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Deployment Method Segment
  9.1.2. Market Attractiveness Index, By Deployment Method Segment
9.2. Cloud-based
  9.2.1. Introduction
  9.2.2. Market Size Analysis, US$ Million, 2018-2028 and Y-o-Y Growth Analysis (%), 2020-2028
9.3. On-Premise

10. BY REGION

10.1. Introduction
  10.1.1. Market Size Analysis, US$ Million, 2018-2028 and Y-o-Y Growth Analysis (%), 2020-2028, By Region
  10.1.2. Market Attractiveness Index, By Region
10.2. North America
  10.2.1. Introduction
  10.2.2. Key Region-Specific Dynamics
  10.2.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Device Type
  10.2.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Deployment Method
  10.2.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
  10.2.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
    10.2.6.1. U.S.
    10.2.6.2. Canada
    10.2.6.3. Mexico
10.3. Europe
  10.3.1. Introduction
  10.3.2. Key Region-Specific Dynamics
  10.3.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Device Type
  10.3.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Deployment Method
  10.3.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
  10.3.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
    10.3.6.1. Germany
    10.3.6.2. U.K.
    10.3.6.3. France
    10.3.6.4. Italy
    10.3.6.5. Spain
    10.3.6.6. Rest of Europe
10.4. South America
  10.4.1. Introduction
  10.4.2. Key Region-Specific Dynamics
  10.4.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Device Type
  10.4.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Deployment Method
  10.4.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
  10.4.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
    10.4.6.1. Brazil
    10.4.6.2. Argentina
    10.4.6.3. Rest of South America
10.5. Asia Pacific
  10.5.1. Introduction
  10.5.2. Key Region-Specific Dynamics
  10.5.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Device Type
  10.5.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Deployment Method
  10.5.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
  10.5.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
    10.5.6.1. China
    10.5.6.2. India
    10.5.6.3. Japan
    10.5.6.4. Australia
    10.5.6.5. Rest of Asia Pacific
10.6. Middle East and Africa
  10.6.1. Introduction
  10.6.2. Key Region-Specific Dynamics
  10.6.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Device Type
  10.6.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Deployment Method
  10.6.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application

11. COMPETITIVE LANDSCAPE

11.1. Key Developments and Strategies
11.2. Company Share Analysis
11.3. Product Benchmarking

12. COMPANY PROFILES

12.1. Paragon Biosciences (Qlarity Imaging LLC) *
  12.1.1. Company Overview
  12.1.2. Product Portfolio and Description
  12.1.3. Key Highlights
  12.1.4. Financial Overview
12.2. Arterys Inc
12.3. Viz.ai, Inc
12.4. Apple Inc
12.5. iSchemaView, inc. (RAPID)
12.6. MaxQ AI Ltd
12.7. Greenfinch Technology
12.8. Siemens Healthineers AG
12.9. Koninklijke Philips N.V.
12.10. VitalConnect(*LIST NOT EXHAUSTIVE)

13. DATAM INTELLIGENCE

13.1. Appendix
13.2. About Us and Services
13.3. Contact Us

LIST OF TABLES

Table 1 Global Software as a Medical Devices Market Value, By Device Type, 2021, 2025 & 2029($ Million)
Table 2 Global Software as a Medical Devices Market Value, By Application, 2021, 2025 & 2029($ Million)
Table 3 Global Software as a Medical Devices Market Value, By Deployment Method, 2021, 2025 & 2029($ Million)
Table 4 Global Software as a Medical Devices Market Value, By Region, 2021, 2025 & 2029($ Million)
Table 5 Global Software as a Medical Devices Market Value, By Device Type, 2021, 2025 & 2029($ Million)
Table 6 Global Software as a Medical Devices Market Value, By Device Type, 2019-2029($ Million)
Table 7 Global Software as a Medical Devices Market Value, By Application, 2021, 2025 & 2029($ Million)
Table 8 Global Software as a Medical Devices Market Value, By Application, 2019-2029($ Million)
Table 9 Global Software as a Medical Devices Market Value, By Deployment Method, 2021, 2025 & 2029($ Million)
Table 10 Global Software as a Medical Devices Market Value, By Deployment Method, 2019-2029($ Million)
Table 11 Global Software as a Medical Devices Market Value, By Region, 2021, 2025 & 2029($ Million)
Table 12 Global Software as a Medical Devices Market Value, By Region, 2019-2029($ Million)
Table 13 North America Software as a Medical Devices Market Value, By Device Type, 2019-2029($ Million)
Table 14 North America Software as a Medical Devices Market Value, By Application, 2019-2029($ Million)
Table 15 North America Software as a Medical Devices Market Value, By Deployment Method, 2019-2029($ Million)
Table 16 North America Software as a Medical Devices Market Value, By Country, 2019-2029($ Million)
Table 17 South America Software as a Medical Devices Market Value, By Device Type, 2019-2029($ Million)
Table 18 South America Software as a Medical Devices Market Value, By Application, 2019-2029($ Million)
Table 19 South America Software as a Medical Devices Market Value, By Deployment Method, 2019-2029($ Million)
Table 20 South America Software as a Medical Devices Market Value, By Country, 2019-2029($ Million)
Table 21 Europe Software as a Medical Devices Market Value, By Device Type, 2019-2029($ Million)
Table 22 Europe Software as a Medical Devices Market Value, By Application, 2019-2029($ Million)
Table 23 Europe Software as a Medical Devices Market Value, By Deployment Method, 2019-2029($ Million)
Table 24 Europe Software as a Medical Devices Market Value, By Country, 2019-2029($ Million)
Table 25 Asia-Pacific Software as a Medical Devices Market Value, By Device Type, 2019-2029($ Million)
Table 26 Asia-Pacific Software as a Medical Devices Market Value, By Application, 2019-2029($ Million)
Table 27 Asia-Pacific Software as a Medical Devices Market Value, By Deployment Method, 2019-2029($ Million)
Table 28 Asia-Pacific Software as a Medical Devices Market Value, By Country, 2019-2029($ Million)
Table 29 Middle East & Africa Software as a Medical Devices Market Value, By Device Type, 2019-2029($ Million)
Table 30 Middle East & Africa Software as a Medical Devices Market Value, By Application, 2019-2029($ Million)
Table 31 Middle East & Africa Software as a Medical Devices Market Value, By Deployment Method, 2019-2029($ Million)
Table 32 Arterys Inc: Overview
Table 33 Arterys Inc: Product Portfolio
Table 34 Arterys Inc: Key Developments
Table 35 Paragon Biosciences (Qlarity Imaging LLC): Overview
Table 36 Paragon Biosciences (Qlarity Imaging LLC): Product Portfolio
Table 37 Paragon Biosciences (Qlarity Imaging LLC): Key Developments
Table 38 Viz.ai, Inc: Overview
Table 39 Viz.ai, Inc: Product Portfolio
Table 40 Viz.ai, Inc: Key Developments
Table 41 Apple Inc: Overview
Table 42 Apple Inc: Product Portfolio
Table 43 Apple Inc: Key Developments
Table 44 iSchemaView, inc. (RAPID): Overview
Table 45 iSchemaView, inc. (RAPID): Product Portfolio
Table 46 iSchemaView, inc. (RAPID): Key Developments
Table 47 MaxQ AI Ltd: Overview
Table 48 MaxQ AI Ltd: Product Portfolio
Table 49 MaxQ AI Ltd: Key Developments
Table 50 Greenfinch Technology: Overview
Table 51 Greenfinch Technology: Product Portfolio
Table 52 Greenfinch Technology: Key Developments
Table 53 Siemens Healthineers AG: Overview
Table 54 Siemens Healthineers AG: Product Portfolio
Table 55 Siemens Healthineers AG: Key Developments
Table 56 Koninklijke Philips N.V.: Overview
Table 57 Koninklijke Philips N.V.: Product Portfolio
Table 58 Koninklijke Philips N.V.: Key Developments
Table 59 VitalConnect: Overview
Table 60 VitalConnect: Product Portfolio
Table 61 VitalConnect: Key Developments

LIST OF FIGURES

Figure 1 Global Software as a Medical Devices Market Share, By Device Type, 2021 & 2029(%)
Figure 2 Global Software as a Medical Devices Market Share, By Application, 2021 & 2029(%)
Figure 3 Global Software as a Medical Devices Market Share, By Deployment Method, 2021 & 2029(%)
Figure 4 Global Software as a Medical Devices Market Share, By Region, 2021 & 2029(%)
Figure 5 Global Software as a Medical Devices Market Value, 2019-2029($ Million)
Figure 6 Global Software as a Medical Devices Market Y-o-Y Growth, By Device Type, 2021-2029(%)
Figure 7 PCs/Laptop: Global Software as a Medical Devices Market Value, 2019-2029($ Million)
Figure 8 Smartphone/tablets: Global Software as a Medical Devices Market Value, 2019-2029($ Million)
Figure 9 Wearable Device: Global Software as a Medical Devices Market Value, 2019-2029($ Million)
Figure 10 Global Software as a Medical Devices Market Y-o-Y Growth, By Application, 2021-2029(%)
Figure 11 Diagnostic: Global Software as a Medical Devices Market Value, 2019-2029($ Million)
Figure 12 Clinical Management: Global Software as a Medical Devices Market Value, 2019-2029($ Million)
Figure 13 Global Software as a Medical Devices Market Y-o-Y Growth, By Deployment Method, 2021-2029(%)
Figure 14 On-Premise: Global Software as a Medical Devices Market Value, 2019-2029($ Million)
Figure 15 Cloud-based: Global Software as a Medical Devices Market Value, 2019-2029($ Million)
Figure 16 Global Software as a Medical Devices Market Y-o-Y Growth, By Region, 2021-2029(%)
Figure 17 North America Software as a Medical Devices Market Value, 2019-2029($ Million)
Figure 18 North America Software as a Medical Devices Market Share, By Device Type, 2021 & 2029(%)
Figure 19 North America Software as a Medical Devices Market Share, By Application, 2021 & 2029(%)
Figure 20 North America Software as a Medical Devices Market Share, By Deployment Method, 2021 & 2029(%)
Figure 21 North America Software as a Medical Devices Market Share, By Country, 2021 & 2029(%)
Figure 22 South America Software as a Medical Devices Market Value, 2019-2029($ Million)
Figure 23 South America Software as a Medical Devices Market Share, By Device Type, 2021 & 2029(%)
Figure 24 South America Software as a Medical Devices Market Share, By Application, 2021 & 2029(%)
Figure 25 South America Software as a Medical Devices Market Share, By Deployment Method, 2021 & 2029(%)
Figure 26 South America Software as a Medical Devices Market Share, By Country, 2021 & 2029(%)
Figure 27 Europe Software as a Medical Devices Market Value, 2019-2029($ Million)
Figure 28 Europe Software as a Medical Devices Market Share, By Device Type, 2021 & 2029(%)
Figure 29 Europe Software as a Medical Devices Market Share, By Application, 2021 & 2029(%)
Figure 30 Europe Software as a Medical Devices Market Share, By Deployment Method, 2021 & 2029(%)
Figure 31 Europe Software as a Medical Devices Market Share, By Country, 2021 & 2029(%)
Figure 32 Asia-Pacific Software as a Medical Devices Market Value, 2019-2029($ Million)
Figure 33 Asia-Pacific Software as a Medical Devices Market Share, By Device Type, 2021 & 2029(%)
Figure 34 Asia-Pacific Software as a Medical Devices Market Share, By Application, 2021 & 2029(%)
Figure 35 Asia-Pacific Software as a Medical Devices Market Share, By Deployment Method, 2021 & 2029(%)
Figure 36 Asia-Pacific Software as a Medical Devices Market Share, By Country, 2021 & 2029(%)
Figure 37 Middle East & Africa Software as a Medical Devices Market Value, 2019-2029($ Million)
Figure 38 Middle East & Africa Software as a Medical Devices Market Share, By Device Type, 2021 & 2029(%)
Figure 39 Middle East & Africa Software as a Medical Devices Market Share, By Application, 2021 & 2029(%)
Figure 40 Middle East & Africa Software as a Medical Devices Market Share, By Deployment Method, 2021 & 2029(%)
Figure 41 Arterys Inc: Financials
Figure 42 Paragon Biosciences (Qlarity Imaging LLC) : Financials
Figure 43 Viz.ai, Inc: Financials
Figure 44 Apple Inc: Financials
Figure 45 iSchemaView, inc. (RAPID): Financials
Figure 46 MaxQ AI Ltd: Financials
Figure 47 Greenfinch Technology: Financials
Figure 48 Siemens Healthineers AG: Financials
Figure 49 Koninklijke Philips N.V.: Financials
Figure 50 VitalConnect: Financials



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