AI/ML-Enabled Medical Devices Market: Current Analysis and Forecast (2024-2032)

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Emphasis on Product Type (Hardware and Software); Clinical Area (Radiology, Cardiology, Hematology, and Others); End-User (Hospitals, Pharmaceutical Companies, and Others); and Region/Country

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UMHE212815

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Report Description

AI-ML-Enabled Medical Devices Market Size & Forecast,AI/ML-Enabled Medical Devices Market Size & Forecast

The AI/ML-enabled medical devices market was valued at approximately ~USD 4 Million and is expected to grow at a strong CAGR of around 26% during the forecast period (2024-2032) owing to the rising demand for smart medical devices.

AI/ML-Enabled Medical Devices Market Analysis

The artificial intelligence and machine learning-enabled medical device market encompasses various products, including diagnostic imaging systems, wearable health monitors, robotic surgery systems, and predictive analytics tools. This market is experiencing rapid growth, driven by technological advancements, increasing demand for personalized healthcare, and the need for more efficient diagnostic and treatment solutions. Company collaborations and innovative product launches also drive the industry’s growth.

For instance, in May 2024, the FDA added more than 120 new AI-enabled medical devices focused on radiology to the list of approvals, including NAEOTOM Alpha by Siemens Medical Solutions USA, Inc., uMR Omega by Shanghai United Imaging Healthcare Co., Ltd., and many more.

Moreover, in October 2023, GE HealthCare stood first in the FDA’s AI-enabled medical device authorization list.

AI/ML-Enabled Medical Devices Market Trends

This section discusses the key market trends that are influencing the various segments of the AI/ML-enabled medical devices market as identified by our team of research experts.

AI-ML-Enabled Medical Devices Market Segmentation

Cardiology Segment Transforming Industry

The cardiology segment in the AI/ML-enabled medical devices market has seen steady growth over the years, driven by various factors. Artificial intelligence and machine learning can also work with large numbers of heart data and different degrees of complexity in short periods and quickly provide the most reliable diagnosis of various diseases, including arrhythmia, coronary artery disease, and heart failure. These technologies make it possible to detect pointers to possible cardiovascular issues before they advance to the normal index of detecting such complications. The Patient information can be used to develop personalized treatment plans and methods such as gene, medical history analysis, and lifestyle choices to assist in the development of an individualized patient care plan. In this regard, the use of such an individual approach enhances optimal results in treatment procedures. These devices will also help in remote cardiac monitoring where the vital signs of the patients and other significant signs can be observed in real nature. This remote monitoring feature enhances patient care since it eliminates meetings with many doctors before an issue can be attended to, as well as ensures that the need for further medical attention is promptly observed where applicable. The key market driver of the AI and machine learning medical device market is the segment involved in cardiology since there is an increasing need for better diagnosis, treatment strategies, and outcomes in patients with cardiovascular diseases. For instance, in January 2024, Clew Medical Ltd. Received FDA authorization for its device CLEWICU System in the cardiovascular sector.

North America is Expected to Grow with Significant CAGR During Forecast Period

Within North America, the U.S. holds a major share of the market. The region’s rapid urbanization, rising investments in the healthcare industry, the growing trend of medical devices owing to the rising demand for personalized treatments, innovative product launches, and the presence of several market players are the major factors boosting the market’s growth in the country.

In March 2024, Siemens Medical Solutions USA, Inc. received FDA authorization for its device NAEOTOM Alpha in the radiology sector.

In March 2024, S-based Beacon Biosignals, Inc. received FDA authorization for its device SleepStageML in the neurology sector.

AI-ML-Enabled Medical Devices Market Trends

AI/ML-Enabled Medical Devices Industry Overview

The AI/ML-enabled medical devices market is competitive, with the presence of several global and international market players. The key players are adopting different growth strategies to enhance their market presence, such as partnerships, agreements, collaborations, new type launches, geographical expansions, and mergers and acquisitions. Some of the major players operating in the market are Aidoc, CANON MEDICAL SYSTEMS CORPORATION, CellaVision, Clarius, GE HealthCare, HYPERFINE, INC., Koninklijke Philips N.V., Medtronic, Nano-X Imaging LTD., Siemens Healthcare Private Limited.

AI/ML-Enabled Medical Devices Market News

In March 2023, Coreline Soft Co., Ltd. received FDA authorization for its device AVIEW CAC in radiology sector.

In March 2023, Eko Health, Inc. received FDA authorization for its device Eko Low Ejection Fraction Tool (ELEFT), in the cardiovascular sector.

AI/ML-Enabled Medical Devices Market Report Coverage

AI-ML-Enabled Medical Devices Market Report Coverage

Reasons to buy this report:

  • The study includes market sizing and forecasting analysis validated by authenticated key industry experts.
  • The report presents a quick review of overall industry performance at one glance.
  • The report covers an in-depth analysis of prominent industry peers with a primary focus on key business financials, type portfolios, expansion strategies, and recent developments.
  • Detailed examination of drivers, restraints, key trends, and opportunities prevailing in the industry.
  • The study comprehensively covers the market across different segments.
  • Deep dive regional level analysis of the industry.

Customization Options:

The global AI/ML-enabled medical devices market can further be customized as per the requirement or any other market segment. Besides this, UMI understands that you may have your own business needs, hence feel free to contact us to get a report that completely suits your requirements.

Frequently Asked Questions (FAQ)

Q1: What is the AI/ML-enabled medical devices market's current market size and growth potential?

Ans: The AI/ML-enabled medical devices market was valued at ~USD 4 billion in 2023 and is expected to grow at a CAGR of 26% during the forecast period (2024-2032).

Q2: What are the driving factors for the growth of the AI/ML-enabled medical devices market?

Ans: The growing trend of smart medical devices, and innovative product launches are driving the AI/ML-enabled medical devices market.

Q3: Which segment has the largest share of the AI/ML-enabled medical devices market by product type?

Ans: The software segment has the largest share of the AI/ML-enabled medical devices market by product type.

Q4: What are the emerging technologies and trends in the AI/ML-enabled medical devices market?

Ans: Enhancing efficiency and customer experience is one of the major trends in the AI/ML-enabled medical devices market.

Q5: Which region will dominate the AI/ML-enabled medical devices market?

Ans: North America is expected to dominate the market during the forecast period.

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1.1.Market Definitions
1.2.Main Objective
1.3.Stakeholders
1.4.Limitation

 

2.1.Research Process of the AI/ML-Enabled Medical Devices Market
2.2.Research Methodology of the AI/ML-Enabled Medical Devices Market
2.3.Respondent Profile

 

3.1.Industry Synopsis
3.2.Segmental Outlook
 3.2.1.Market Growth Intensity
3.3.Regional Outlook

 

4.1.Drivers 
4.2.Opportunity
4.3.Restraints
4.4.Trends 
4.5.PESTEL Analysis
4.6.Demand Side Analysis
4.7.Supply Side Analysis
 4.7.1.Merger & Acquisition
 4.7.2.Investment Scenario
 4.7.3.Industry Insights: Leading Startups and Their Unique Strategies

 

5.1.    Regional Pricing Analysis
5.2.    Price Influencing Factors
6GLOBAL AI/ML-ENABLED MEDICAL DEVICES MARKET REVENUE (USD BN), 2022-2032F
7.1.Hardware   
7.2.Software    
 7.2.1.Software as a Medical Device 
 7.2.2.Software in a Medical Device 
 7.2.3.Software Used in the Manufacture of a Medical Device

 

8.1.Radiology
8.2.Cardiology
8.3.Hematology
8.4.Others 

 

9.1.Hospitals 
9.2.Pharmaceutical Companies
9.3.Others 

 

10.1.North America    
 10.1.1.U.S.  
 10.1.2.Canada  
 10.1.3.Rest of North America
10.2.Europe    
 10.2.1.Germany  
 10.2.2.U.K.  
 10.2.3.France  
 10.2.4.Italy  
 10.2.5.Spain  
 10.2.6.Rest of Europe 
10.3.Asia-Pacific   
 10.3.1.China  
 10.3.2.Japan  
 10.3.3.India  
 10.3.4.Rest of Asia-Pacific 
10.4.Rest of World   

 

11.1.Marginal Analysis
11.2.List of Market Participants

 

12.1.Competition Dashboard 
12.2.Competitor Market Positioning Analysis
12.3.Porter Five Forces Analysis 

 

13.1.Aidoc   
 13.1.1.Company Overview 
 13.1.2.Key Financials 
 13.1.3.SWOT Analysis 
 13.1.4.Product Portfolio 
 13.1.5.Recent Developments
13.2.CANON MEDICAL SYSTEMS CORPORATION
13.3.CellaVision  
13.4.Clarius   
13.5.GE HealthCare  
13.6.HYPERFINE, INC.  
13.7.Koninklijke Philips N.V. 
13.8.Medtronic  
13.9.Nano-X Imaging LTD. 
13.10.Siemens Healthcare Private Limited
14ACRONYMS & ASSUMPTION
15ANNEXURE

Research Methodology

Research Methodology for the AI/ML-Enabled Medical Devices Market Analysis (2024-2032)

Analyzing the historical market, estimating the current market, and forecasting the future market of the global AI/ML-enabled medical devices market were the three major steps undertaken to create and analyze the adoption of AI/ML-enabled medical devices in major regions globally. Exhaustive secondary research was conducted to collect the historical market numbers and estimate the current market size. Secondly, to validate these insights, numerous findings and assumptions were taken into consideration. Moreover, exhaustive primary interviews were also conducted, with industry experts across the value chain of the global AI/ML-enabled medical devices market. Post assumption and validation of market numbers through primary interviews, we employed a top-down/bottom-up approach to forecasting the complete market size. Thereafter, market breakdown and data triangulation methods were adopted to estimate and analyze the market size of segments and sub-segments of the industry pertains to. Detailed methodology is explained below:

Analysis of Historical Market Size

Step 1: In-Depth Study of Secondary Sources:

Detail secondary study was conducted to obtain the historical market size of the AI/ML-enabled medical devices market through company internal sources such as annual reports & financial statements, performance presentations, press releases, etc., and external sources including journals, news & articles, government publications, competitor publications, sector reports, third-party database, and other credible publications.

Step 2: Market Segmentation:

After obtaining the historical market size of the AI/ML-enabled medical devices market, we conducted a detailed secondary analysis to gather historical market insights and share for different segments & sub-segments for major regions. Major segments are included in the report as product type, clinical area, end-user, and regions. Further country-level analyses were conducted to evaluate the overall adoption of testing models in that region.

Step 3: Factor Analysis:

After acquiring the historical market size of different segments and sub-segments, we conducted a detailed factor analysis to estimate the current market size of the AI/ML-enabled medical devices market. Further, we conducted factor analysis using dependent and independent variables such as product type, clinical area, end-user, and regions of the AI/ML-enabled medical devices market. A thorough analysis was conducted for demand and supply-side scenarios considering top partnerships, mergers and acquisitions, business expansion, and type launches in the AI/ML-enabled medical devices market sector across the globe.

Current Market Size Estimate & Forecast

Current Market Sizing: Based on actionable insights from the above 3 steps, we arrived at the current market size, key players in the global AI/ML-enabled medical devices market, and market shares of the segments. All the required percentage shares split, and market breakdowns were determined using the above-mentioned secondary approach and were verified through primary interviews.

Estimation & Forecasting: For market estimation and forecast, weights were assigned to different factors including drivers & trends, restraints, and opportunities available for the stakeholders. After analyzing these factors, relevant forecasting techniques i.e., the top-down/bottom-up approach were applied to arrive at the market forecast for 2030 for different segments and sub-segments across the major markets globally. The research methodology adopted to estimate the market size encompasses:

  • The industry’s market size, in terms of revenue (USD) and the adoption rate of the AI/ML-enabled medical devices market across the major markets domestically
  • All percentage shares, splits, and breakdowns of market segments and sub-segments
  • Key players in the global AI/ML-enabled medical devices market in terms of types offered. Also, the growth strategies adopted by these players to compete in the fast-growing market

Market Size and Share Validation

Primary Research: In-depth interviews were conducted with the Key Opinion Leaders (KOLs) including Top Level Executives (CXO/VPs, Sales Head, Marketing Head, Operational Head, Regional Head, Country Head, etc.) across major regions. Primary research findings were then summarized, and statistical analysis was performed to prove the stated hypothesis. Inputs from primary research were consolidated with secondary findings, hence turning information into actionable insights.

Split of Primary Participants in Different Regions

AI ML-Enabled Medical Devices Market Graph

Market Engineering

The data triangulation technique was employed to complete the overall market estimation and to arrive at precise statistical numbers for each segment and sub-segment of the global AI/ML-enabled medical devices market. Data was split into several segments & sub-segments post studying various parameters and trends in the areas of the product type, clinical area, end-user, and regions in the global AI/ML-enabled medical devices market.

The main objective of the Global AI/ML-Enabled Medical Devices Market Study

The current & future market trends of the global AI/ML-enabled medical devices market were pinpointed in the study. Investors can gain strategic insights to base their discretion for investments on the qualitative and quantitative analysis performed in the study. Current and future market trends determined the overall attractiveness of the market at a regional level, providing a platform for the industrial participant to exploit the untapped market to benefit from a first-mover advantage. Other quantitative goals of the studies include:

  • Analyze the current and forecast market size of the AI/ML-enabled medical devices market in terms of value (USD). Also, analyze the current and forecast market size of different segments and sub-segments.
  • Segments in the study include areas of the product type, clinical area, end-user, and regions.
  • Define and analysis of the regulatory framework for the AI/ML-enabled medical devices
  • Analyze the value chain involved with the presence of various intermediaries, along with analyzing customer and competitor behaviors of the industry.
  • Analyze the current and forecast market size of the AI/ML-enabled medical devices market for the major region.
  • Major countries of regions studied in the report include Asia Pacific, Europe, North America, and the Rest of the World
  • Company profiles of the AI/ML-enabled medical devices market and the growth strategies adopted by the market players to sustain in the fast-growing market.
  • Deep dive regional level analysis of the industry

 

You can also purchase parts of this report. Do you want to check out a section wise
price list?

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