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PUBLISHER: BCC Research | PRODUCT CODE: 1172506

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PUBLISHER: BCC Research | PRODUCT CODE: 1172506

Software as a Medical Device: Global Market Outlook

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PAGES: 59 Pages
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Highlights:

This report provides a comprehensive analysis of the global market for software as a medical device. It presents the current and historical market revenue data estimation based on the product type, and by region. The report examines new and emerging trends and their impact on current and future market dynamics.

Report Scope:

In this report, the market has been segmented based on product type and geography. The report provides an overview of the software as a medical device market and analyzes market trends. Using 2021 as the base year, the report provides estimated market data for the forecast period, 2022-2027. Revenue forecasts for this period are segmented based on product type and geography. Market values have been estimated based on the total revenue of SaMD manufacturers and key vendors.

The report covers the market for software as a medical device across different regions and countries. It also highlights major trends, opportunities, restraints that affect the market of SaMD. The report estimates the global market for SaMD in 2021 and provides projections for the expected market size through 2027.

The scope of the study includes software as a medical devices and operating platforms such as desktops/laptops, smartphones/tablets, and wearable devices.

Report Includes:

  • A brief general outlook of the global market for software as a medical device (SaMD)
  • Analyses of the global market trends, with historic revenue data for 2019-2021, estimates for 2022, and projections of compound annual growth rates (CAGRs) through 2027
  • Understanding of the upcoming market opportunities for SaMD products market and digital health solutions, and areas of focus to forecast the market into various segments and sub-segments
  • Estimation of the actual market size and revenue forecast for software as a medical device market, and corresponding market share analysis by product type and region
  • Review of the impact of COVID-19 pandemic on the medical devices market
  • Market share analysis of leading medical device manufacturers, their research priorities, technology advancements, and market development strategies
  • Company profiles of the leading industry players, including Abbott Laboratories, Arterys, DexCom Inc. and Hyperfine Inc.
Product Code: MDS080A

Table of Contents

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
Product Code: MDS080A

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

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
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