Table of Content

Chapter 1 Market Outlook
1.1 Market Snapshot

Chapter 2 Executive Summary

Chapter 3 Market Definitions and Background
3.1 Overview
3.2 Definitions and Background
3.2.1 Difference Between Medical Device Software and SaMD
3.2.2 SaMD Utilizing Artificial Intelligence and Machine Learning (AI/ML)
3.2.3 Examples of Software that are not Software as a Medical Device
3.2.4 Five Applications of Software as a Medical Device
3.3 Regulation of Software as a Medical Device (SaMD)
3.3.1 Historic Foundations
3.3.2 Outlook of Regulatory Process in 2021
3.3.3 Future Scenario
3.4 International SaMD Regulations
3.4.1 SaMD Regulation in the EU
3.4.2 SaMD Regulation in the U.S.

Chapter 4 Market Dynamics
4.1 Market Drivers
4.2 Market Trends
4.3 Market Opportunities
4.4 Market Restraints

Chapter 5 Market Breakdown by Product
5.1 Introduction
5.2 SaMD: Desktops/Laptops
5.3 SaMD: Smartphone/Tablets
5.4 SaMD: Wearable Devices

Chapter 6 Market Breakdown by Region
6.1 Global Software as a Medical Device Market Size by Region
6.1.1 North America
6.1.2 Europe
6.1.3 Asia-Pacific
6.1.4 Rest of the World

Chapter 7 COVID-19 Impact on the SaMD Market
7.1 Introduction
7.2 Impact of COVID-19 on MedTech Industry
7.3 COVID-19 Impact on SaMD Market

Chapter 8 Competitive Landscape
8.1 Industry Scenario
8.2 Company Shares
8.3 Competitive Analysis

Chapter 9 Company Profiles
9.1 SaMD Manufacturers, Developers and Vendors
ABBOTT LABORATORIES
ARTERYS
DEXCOM INC.
FUJIFILM HOLDINGS CORP.
GENERAL ELECTRIC CO.
HYPERFINE, INC.
ICAD INC.
KONINKLIJKE PHILIPS N.V.
MEDTRONIC PLC
MITAC INTERNATIONAL CORP.
OMEGA MEDICAL IMAGING LLC
SIEMENS HEALTHINEERS

Chapter 10 Project Scope and Methodology
10.1 Scope of Report
10.2 Methodology
10.3 Analyst’s Credentials
10.4 Related BCC Research Reports



List of Figures


Summary Figure : Global Market Share for Software as a Medical Device, by Region, 2021
Figure 1 : Global Sofware as a Medical Device Market, by Product, 2019-2027
Figure 2 : Global Sofware as a Medical Device Market Share, by Product, 2021
Figure 3 : Global SaMD Desktop/Laptop Market, by Region, 2019-2027
Figure 4 : Global SaMD Desktop/Laptop Market Market Share, by Region, 2021
Figure 5 : Global SaMD Smartphone/Tablet Market, by Region, 2019-2027
Figure 6 : Global SaMD Smartphone/Tablet Market Share, by Region, 2021
Figure 7 : Global SaMD Wearable Device Market, by Region, 2019-2027
Figure 8 : Global SaMD Wearable Device Market Share, by Region, 2021
Figure 9 : Global SaMD Market, by Region
Figure 10 : Global Software as a Medical Device Market Share, by Region, 2021
Figure 11 : North American Software as a Medical Device Market Share, by Country, 2021
Figure 12 : European Software as a Medical Device Market Share, by Country, 2021
Figure 13 : Asia-Pacific Software as a Medical Device Market Share, by Country, 2021
Figure 14 : Global Software as a Medical Device Market Share, by Company, 2021
Figure 15 : Global SaMD Desktop/Laptop Market Share, by Company, 2021
Figure 16 : Global SaMD Smartphone/Tablet Market Share, by Company, 2021
Figure 17 : Global SaMD Wearable Device Market Share, by Company, 2021
Figure 18 : Abbott: Annual Revenue, 2018-2021
Figure 19 : Abbott: Revenue Share, by Business Segment, 2021
Figure 20 : Dexcom Inc.: Annual Revenue, 2019-2021
Figure 21 : Fujifilm Holdings Corp.: Annual Revenue, 2019-2021
Figure 22 : General Electric Co.: Healthcare Segment, Annual Revenue, 2018-2021
Figure 23 : General Electric Co.: Healthcare Segment, Revenue Share, by Division, 2021
Figure 24 : Koninklijke Philips N.V.: Annual Revenue, 2018-2021
Figure 25 : Koninklijke Philips N.V.: Revenue Share, by Business Segment, 2021
Figure 26 : Medtronic: Annual Revenue, 2019-2021
Figure 27 : Medtronic: Revenue Share, by Business Segment, 2021
Figure 28 : Medtronic: Revenue Share, by Geography, 2021
Figure 29 : Siemens Healthineers: Annual Revenue, 2019-2021
Figure 30 : Siemens Healthineers: Revenue Share, by Business Segment, 2021
Figure 31 : Siemens Healthineers: Revenue Share, by Geography, 2021

List of Tables

Summary Table : Global Software as a Medical Device Market, by Region, Through 2027
Table 1 : Global Software as a Medical Device Market, by Product, Through 2027
Table 2 : Global SaMD Desktop/Laptop Market, by Region, Through 2027
Table 3 : Global SaMD Smartphone/Tablet Market, by Region, Through 2027
Table 4 : Global SaMD Wearable Device Market, by Region, Through 2027
Table 5 : Global Software as a Medical Device Market, by Region, Through 2027
Table 6 : North American Software as a Medical Device Market, by Country, Through 2027
Table 7 : European Software as a Medical Device Market, by Country, Through 2027
Table 8 : Asia-Pacific Software as a Medical Device Market, by Country, Through 2027
Table 9 : Rest of the World Software as a Medical Device Market, Through 2027
Table 10 : Arterys: Product Portfolio
Table 11 : Fujifilm Holdings Corp.: Product Portfolio
Table 12 : General Electric Co.: Product portfolio
Table 13 : Hyperfine Inc.: Product portfolio
Table 14 : iCAD INC.: Product Portfolio
Table 15 : Koninklijke Philips N.V.: Product Portfolio
Table 16 : Medtronic: Product Portfolio
Table 17 : Siemens Healthineers: Product Portfolio