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市場調查報告書
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2109020

醫療設備專案（SaMD）：市場洞察、競爭格局與市場預測 - 2034 年

Software as a Medical Device (SaMD) - Market Insights, Competitive Landscape, and Market Forecast - 2034
出版日期: | 出版商: DelveInsight | 英文 150 Pages | 商品交期: 2-10個工作天內

價格

概述：

  • 2025年全球醫療設備專案市場價值為21億美元，預計2034年將達到89億美元。
  • 在 2026 年至 2034 年的預測期內，市場預計將以 17.4% 的複合年成長率成長，這得益於人工智慧 (AI) 和機器學習融入臨床軟體、數位療法和遠距醫療的發展、軟體和自適應演算法監管流程的成熟，以及對提高醫療保健品質的診斷和決策支援的需求。
  • 按類別分類，預計到 2025 年，診斷和篩檢軟體細分市場將佔 42% 的佔有率，從而推動醫療設備程序市場的發展。
  • 按應用領域分類，放射學和醫學影像領域預計將引領醫療設備專案市場，到 2025 年將佔 34% 的佔有率。
  • 就部署方式而言，預計到 2025 年，基於雲端的部署方式將引領醫療設備程序市場，佔據 62% 的市場。
  • 按最終用戶分類，預計醫院和診所領域將引領醫療設備專案市場，到 2025 年將佔市場佔有率的 54%。
  • 截至 2025 年，北美在醫療設備專案市場中佔據最大佔有率，為 45%，但預計到 2034 年，亞太地區將實現最快成長。

醫療設備程式是指設計用於一種或多種醫療用途的軟體，它本身並非硬體醫療設備的一部分，而是獨立完成這些用途的軟體。此範圍涵蓋診斷和篩檢軟體（包括用於分析醫學影像和數據的AI工具）、為臨床管理提供資訊和指導的臨床決策支援軟體、用於治療和管理疾病的數位療法以及監測和治療計劃軟體。這些程式運行於通用運算平台，並擴大得到人工智慧和機器學習的支援。代表性產品包括用於糖尿病視網膜病變的自主診斷軟體LumineticsCore；臨床AI分診和檢測工具Viz.ai和Aidoc；以及WellDoc等公司開發的數位療法。該市場由國際醫療設備監管機構論壇（IMDRF）框架定義，並受美國食品藥物管理局（FDA）、歐盟醫療設備法規（MDR）以及符合這些法規的國家法規結構的監管。當前市場格局由人工智慧的融合、數位療法的成長以及軟體和自適應演算法監管途徑的成熟所塑造。

醫療設備項目（SaMD）市場的主要市場促進因素

  • 將人工智慧 (AI) 和機器學習技術整合到臨床軟體中。美國食品藥物管理局(FDA) 已大幅增加核准的具備人工智慧功能的醫療設備數量，而且這一數字還在持續成長。
  • 擴大數位療法和軟體為基礎的治療方法在慢性疾病、行為障礙和神經系統疾病的應用。
  • 軟體和自適應演算法監管流程的成熟。這包括針對人工智慧軟體的「預定變更管理計劃（PDCP）」。
  • 對診斷和臨床決策支援的需求日益成長，以提高醫療服務的準確性、速度和可近性。
  • 醫療設備計畫支援遠端監測、遠端醫療和互聯護理的擴展。
  • 慢性病負擔日益加重，對擴充性的、基於軟體的診斷、監測和治療的需求不斷成長。
  • 部署雲端運算和通用運算平台，以大規模交付醫療設備專案（SaMD）。

推動醫療設備專案（SaMD）市場成長的因素

市場促進因素

將人工智慧 (AI) 和機器學習整合到臨床軟體中

推動醫療設備市場發展的根本動力在於人工智慧 (AI) 和機器學習技術與臨床軟體的整合，這徹底改變了診斷、監測和決策支援的方式。 AI 和機器學習使軟體能夠分析大量的醫療數據，包括影像、生理訊號、基因數據和電子健康記錄，從而能夠檢測人類難以識別的模式和病症。這些技術與醫療設備的融合徹底革新了診斷、監測、治療支援和決策。美國食品藥物管理局(FDA) 已大幅增加其核准的 AI 驅動型醫療設備的數量，而這一數字仍在持續成長。目前，核准產品已超過 1000 種，是過去幾年的兩倍，其中大部分是用於分析放射學、循環系統和其他專科領域的影像和數據的軟體。由於 AI 軟體能夠檢測和分診疾病、優先處理高優先級觀察、輔助診斷、提案循證建議，並且能夠從實際臨床應用中學習並不斷提升自身性能，因此它是一個快速發展的領域。人工智慧對臨床軟體的變革、人工智慧軟體的批准以及人工智慧在診斷和決策支援方面的價值，正在推動市場成長。隨著人工智慧和機器學習技術被整合到臨床軟體中，以及獲批准的人工智慧軟體不斷擴展，市場正在蓬勃發展。人工智慧和機器學習技術與臨床軟體的整合，是「醫療設備計畫」市場在整個預測期內持續成長的基礎。

數位療法和基於軟體的治療技術的發展

數位療法和軟體療法的蓬勃發展是推動醫療設備計畫範圍從診斷擴展到治療的關鍵驅動力。數位療法是指透過實證治療性介入來治療、管理或預防疾病的軟體，目前正被開發並獲準用於治療慢性疾病、行為障礙和神經系統疾病，包括糖尿病、物質使用障礙和其他疾病。數位療法將行為、認知和生活方式介入與軟體交付相結合，透過患者在通用裝置上使用的應用程式來治療疾病。已通過核准的數位療法提供認知行為療法、疾病管理和神經系統治療。數位療法的發展得益於其高度擴充性和易用的軟體療法的價值、臨床療效的證據以及對治療慢性疾病和行為障礙的需求，從而將「醫療設備計畫」的範圍從診斷和監測擴展到治療。數位療法可以補充或取代藥物療法，將治療擴展到服務不足的人群，並支持慢性疾病和行為障礙的管理，其開發和批准正在擴大市場。隨著數位療法的發展以及軟體療法的研發和獲批，「醫療設備計畫」市場正向治療領域擴展。在預測期內，數位療法和軟體療法的成長將持續支撐對「醫療設備計畫」的需求。

市場限制因素

醫療設備程序市場面臨許多相互關聯的限制因素，阻礙其成長。其中最主要的因素是監管的複雜性和負擔。醫療設備程序與醫療設備一樣受到監管，需要獲得授權或批准，並需提供臨床證據、品質保證和生命週期管理。向監管機構申請和確保合規的成本、時間和複雜性都相當高，尤其對於高風險軟體或涉及多個司法管轄區的軟體而言，這可能成為小規模開發商的一大障礙。

自適應和學習演算法的監管仍面臨許多挑戰。能夠學習和改變的人工智慧（AI）軟體對傳統的醫療設備核准模式構成了挑戰。雖然可以透過預先設定的變更管理計劃來應對，但這些計劃的實施仍處於早期階段，目前尚不允許在沒有預先設定的協議和檢驗的情況下進行完全自主的持續學習。報銷是一大難題。醫療設備項目和數位療法的報銷範圍有限、不斷變化且缺乏一致性。缺乏既定的報銷途徑限制了經營模式的發展和應用。

臨床檢驗和證據產生需要投入大量精力和資金。軟體必須證明其安全性、有效性和臨床效益，而產生臨床證據則需要研究、時間和投資。臨床部署和整合面臨諸多障礙，例如臨床醫生的接受度、工作流程整合、與電子健康記錄和臨床系統的整合以及價值證明，這些都會減緩軟體在臨床環境中的應用。資料隱私、安全性和品質義務、偏倚風險以及針對整個目標族群的效能要求都會增加合規負擔和風險。此外，與軟體驅動的決策相關的法律責任和法律義務也引發了法律和臨床問題。這些因素共同限制了部署的速度和範圍，要求開發人員證明其符合監管要求、具備臨床證據、獲得報銷並體現價值，以維持成長。

目錄

第1章：引言

  • 調查範圍
  • 市場區隔
  • 市場概覽

第2章：醫療設備項目（SaMD）市場：執行摘要

  • 主要亮點和市場概覽

第3章：醫療設備項目（SaMD）市場：關鍵影響因素

  • 市場促進因素
    • 將人工智慧 (AI) 和機器學習整合到臨床軟體中
    • 數位療法和基於軟體的治療的發展
    • 軟體和自適應演算法法規結構的成熟
    • 診斷支援、互聯醫療和高度擴充性的軟體
  • 市場限制因素
    • 法規的複雜性和自適應演算法的挑戰
    • 報銷限制和臨床有效性檢驗
    • 臨床環境中的實施、整合與法律責任
  • 市場機遇
    • 人工智慧、數位療法和自適應軟體
    • 新興市場和互聯醫療

第4章：人工智慧、地緣政治、貿易與經濟趨勢

第5章：監理分析

  • 美國
  • 歐洲
  • 日本
  • 中國

第6章：波特五力分析

第7章醫療設備項目（SaMD）市場：評估

  • 按類型
    • 診斷及篩檢軟體
    • 臨床決策支援軟體
    • 數位療法
    • 監測和治療計劃軟體
  • 透過使用
    • 放射學和醫學影像
    • 循環系統
    • 神經病學
    • 眼科
    • 其他
  • 不同的發展
    • 基於雲端的
    • 本地部署和嵌入式
  • 最終用戶
    • 醫院和診所
    • 病人和消費者
    • 診斷和影像中心
  • 按地區
    • 北美洲
    • 歐洲
    • 亞太地區
    • 世界其他地區

第8章：醫療設備專案（SaMD）市場：競爭格局

  • 競爭分析
  • 企業市場占有率分析（加值服務）

第9章：醫療設備專案（SaMD）市場：新創企業資金籌措與投資趨勢

第10章：公司簡介與產品簡介

  • Koninklijke Philips NV
  • Siemens Healthineers AG
  • GE HealthCare Technologies Inc.
  • Medtronic plc
  • Aidoc Medical Ltd.
  • Viz.ai, Inc.
  • Digital Diagnostics Inc.
  • HeartFlow, Inc.
  • Cognoa, Inc.
  • Huma Therapeutics Limited

第11章：KOL的觀點

第12章：專案式教學方法

第13章：關於 DelveInsight

第14章 免責聲明與聯絡方式

Product Code: DIMDCL0964

Software as a Medical Device (SaMD) Market Summary

Overview:

  • The global software as a medical device market was valued at USD 2.10 billion in 2025 and is projected to reach USD 8.90 billion by 2034.
  • The market is expected to expand at a CAGR of 17.4% during the forecast period 2026-2034, supported by the integration of artificial intelligence and machine learning into clinical software, the growth of digital therapeutics and remote care, the maturation of regulatory pathways for software and adaptive algorithms, and the demand for diagnostic and decision support that improves care.
  • By type, the diagnostic and screening software segment dominated the software as a medical device market with a 42% share in 2025.
  • By application, the radiology and medical imaging segment dominated the software as a medical device market with a 34% share in 2025.
  • By deployment, the cloud-based segment dominated the software as a medical device market with a 62% share in 2025.
  • By end-user, the hospitals and clinics segment dominated the software as a medical device market with a 54% share in 2025.
  • North America accounted for the largest share of the software as a medical device market at 45% in 2025, while Asia-Pacific is anticipated to register the fastest growth through 2034.

Software as a medical device is software intended to be used for one or more medical purposes that performs those purposes without being part of a hardware medical device. The scope encompasses diagnostic and screening software, including artificial intelligence tools that analyze medical images and data, clinical decision support software that informs and drives clinical management, digital therapeutics that treat and manage disease, and monitoring and treatment planning software, running on general-purpose computing platforms and increasingly powered by artificial intelligence and machine learning. Leading products include the LumineticsCore autonomous diagnostic software for diabetic retinopathy, the Viz.ai and Aidoc clinical artificial intelligence triage and detection tools, and digital therapeutics such as those developed by WellDoc and others, and the market is defined by the International Medical Device Regulators Forum framework and regulated by the Food and Drug Administration, the European Union Medical Device Regulation, and aligned national frameworks. The contemporary market is shaped by the integration of artificial intelligence, the growth of digital therapeutics, and the maturation of regulatory pathways for software and adaptive algorithms.

Software as a Medical Device (SaMD) Market Key Growth Drivers

  • Integration of artificial intelligence and machine learning into clinical software, with the Food and Drug Administration having authorized a large and growing number of artificial intelligence-enabled devices.
  • Growth of digital therapeutics and software-based treatment for chronic, behavioral, and neurological conditions.
  • Maturation of regulatory pathways for software and adaptive algorithms, including the predetermined change control plan for artificial intelligence-enabled software.
  • Demand for diagnostic and clinical decision support that improves the accuracy, speed, and access of care.
  • Growth of remote monitoring, telehealth, and connected care that software as a medical device supports.
  • Rising burden of chronic disease and the demand for scalable software-based diagnosis, monitoring, and treatment.
  • Adoption of cloud and general-purpose computing platforms that deliver software as a medical device at scale.

Key Companies in Software as a Medical Device (SaMD) Market

The leading participants in the software as a medical device market include the following:

  • Koninklijke Philips N.V.
  • Siemens Healthineers AG
  • GE HealthCare Technologies Inc.
  • Medtronic plc
  • Aidoc Medical Ltd.
  • Viz.ai, Inc.
  • Digital Diagnostics Inc.
  • HeartFlow, Inc.
  • Cognoa, Inc.
  • Huma Therapeutics Limited

Factors Contributing to the Growth of the Software as a Medical Device (SaMD) Market

Market Drivers

Integration of Artificial Intelligence and Machine Learning into Clinical Software

The foundational driver of the software as a medical device market is the integration of artificial intelligence and machine learning into clinical software, which has transformed diagnosis, monitoring, and decision support. Artificial intelligence and machine learning enable software to analyze large volumes of medical data, including images, physiological signals, genetic data, and electronic health records, to detect patterns and conditions difficult for humans to detect, and the integration of these technologies into software as a medical device has revolutionized diagnostics, monitoring, treatment support, and decision-making. The Food and Drug Administration has authorized a large and growing number of artificial intelligence-enabled medical devices, with the authorized list expanding to exceed a thousand entries and double from earlier years, and the majority are software that analyzes images and data in radiology, cardiology, and other specialties. Artificial intelligence software detects and triages disease, prioritizes urgent findings, supports diagnosis, and recommends evidence-based actions, and its ability to learn from real-world use and improve performance makes it a rapidly expanding area of development. The transformation of clinical software by artificial intelligence, the authorization of artificial intelligence-enabled software, and the value of artificial intelligence in diagnosis and decision support drive the growth of the market. As artificial intelligence and machine learning are integrated into clinical software and as authorized artificial intelligence software expands, the market grows. The integration of artificial intelligence and machine learning into clinical software anchors the growth of the software as a medical device market across the forecast period.

Growth of Digital Therapeutics and Software-Based Treatment

The growth of digital therapeutics and software-based treatment is a defining driver that expands software as a medical device from diagnosis into treatment. Digital therapeutics are software that treats, manages, or prevents disease through evidence-based therapeutic interventions, and they have been developed and cleared for chronic, behavioral, and neurological conditions, including diabetes, substance use, and other disorders. Digital therapeutics integrate behavioral, cognitive, and lifestyle interventions with software delivery, treating conditions through applications that patients use on general-purpose devices, and cleared digital therapeutics deliver cognitive behavioral therapy, disease management, and neurological therapy. The growth of digital therapeutics is driven by the value of scalable, accessible, software-based treatment, the evidence of clinical efficacy, and the demand for treatment of chronic and behavioral conditions, and it expands software as a medical device from diagnosis and monitoring into treatment. Digital therapeutics complement or substitute for pharmacotherapy, extend treatment to underserved populations, and support the management of chronic and behavioral conditions, and their development and clearance expand the market. As digital therapeutics grow and as software-based treatment is developed and cleared, the software as a medical device market expands into treatment. The growth of digital therapeutics and software-based treatment sustains demand for software as a medical device across the forecast period.

Market Restraints

The software as a medical device market faces several interrelated restraints that temper its growth. The foremost is the complexity and burden of regulation, since software as a medical device is regulated as a medical device requiring clearance or approval, clinical evidence, and quality and lifecycle management, and the cost, time, and complexity of regulatory submission and compliance, particularly for higher-risk software and across multiple jurisdictions, are substantial and can be a barrier, especially for smaller developers.

The challenge of regulating adaptive and learning algorithms persists, since artificial intelligence software that learns and changes challenges the traditional model of device authorization, and while the predetermined change control plan addresses this, its adoption is still developing, and fully autonomous continuous learning is not yet permitted without predetermined protocols and validation. Reimbursement is a significant challenge, since the reimbursement of software as a medical device and digital therapeutics is limited, evolving, and inconsistent, and the absence of established reimbursement pathways constrains the business model and adoption.

Clinical validation and evidence generation are demanding and costly, since software must demonstrate safety, effectiveness, and clinical benefit, and the generation of clinical evidence requires studies, time, and investment. Clinical adoption and integration face barriers of clinician acceptance, workflow integration, integration with electronic health records and clinical systems, and the demonstration of value, and the adoption of software into clinical practice can be slow. Data privacy, security, and quality obligations, and the risk of bias and the requirement for performance across populations, add compliance burden and risk. Liability and the assignment of responsibility for software-driven decisions raise legal and clinical questions. Together, these factors moderate the pace and scope of adoption and require developers to demonstrate regulatory compliance, clinical evidence, reimbursement, and value to sustain growth.

Software as a Medical Device (SaMD) Market Segment Analysis

The global software as a medical device market is segmented by type (diagnostic and screening software, clinical decision support software, digital therapeutics, and monitoring and treatment planning software), by application (radiology and medical imaging, cardiology, neurology, ophthalmology, and others), by deployement (cloud-based and on premise and embedded), and by end-users (hospitals, patients and consumers, diagnostic and imagaing centers,, and others) by geography (North America, Europe, Asia-Pacific, and the Rest of the World).

By Type

Dominant Subsegment: Diagnostic and Screening Software.

The diagnostic and screening software category is expected to dominate the market. The diagnostic and screening software segment accounted for a 42% share of the software as a medical device market in 2025. Diagnostic and screening software, including the artificial intelligence tools that analyze medical images and data to detect, characterize, and triage disease, is the leading type because it is the largest and most mature category of software as a medical device, comprising the majority of authorized artificial intelligence-enabled software and addressing the high-value applications of diagnosis and screening. The dominance of the segment reflects the maturity and volume of diagnostic artificial intelligence, the concentration of authorized software in diagnosis and screening, and the clinical and commercial value of accurate and scalable diagnosis. Diagnostic and screening software analyzes images and data in radiology, cardiology, ophthalmology, pathology, and other specialties to detect and triage disease, and the majority of authorized artificial intelligence-enabled devices are diagnostic software. The maturity of diagnostic artificial intelligence, the volume of authorized diagnostic software, and the value of diagnosis and screening drive the segment. While clinical decision support, digital therapeutics, and monitoring software are important and growing types, the maturity, volume, and value of diagnostic and screening software sustain the leadership of the diagnostic and screening software segment across the forecast period.

By Application

Dominant Subsegment: Radiology and Medical Imaging.

The radiology and medical imaging category is expected to dominate the market. The radiology and medical imaging segment accounted for a 34% share of the software as a medical device market in 2025. Radiology and medical imaging is the leading application because it is the most developed and highest-volume area of software as a medical device, with the majority of artificial intelligence-enabled software analyzing medical images to detect, characterize, and triage disease. The dominance of the segment reflects the concentration of artificial intelligence software in imaging, the volume and value of imaging analysis, and the maturity of imaging artificial intelligence. Software analyzes radiological images, including computed tomography, magnetic resonance, and other modalities, to detect and triage conditions such as stroke, fractures, nodules, and other findings, prioritizing urgent cases and supporting radiologists; the majority of authorized artificial intelligence software is in radiology and imaging. The volume of imaging, the value of imaging analysis and triage, and the maturity of imaging artificial intelligence drive the segment. While cardiology, ophthalmology, neurology, oncology, and other applications are significant and growing, the concentration, volume, and maturity of radiology and medical imaging sustain the leadership of the radiology and medical imaging segment across the forecast period.

Software as a Medical Device (SaMD) Market Region Analysis

Dominant Region: North America

North America accounted for a 45% share of the global software as a medical device market in 2025, representing the highest regional market share globally. The leadership of the region reflects the advanced regulatory framework for software and artificial intelligence, the concentration of clinical artificial intelligence and digital health companies, the advanced adoption of clinical software, and the strength of research and investment. The United States is the largest national market, supported by the Food and Drug Administration framework and pathways for software and artificial intelligence-enabled devices, the authorization of a large and growing number of artificial intelligence-enabled devices, the concentration of clinical artificial intelligence, imaging, and digital therapeutics companies, and the advanced adoption of clinical software. The Food and Drug Administration has developed tailored policies, pathways, and guidance for software as a medical device, including the predetermined change control plan for artificial intelligence-enabled software, and the advanced healthcare and technology ecosystem supports the development and adoption of software. The leading clinical artificial intelligence, imaging, and digital therapeutics companies are headquartered or operate extensively in the region, and the adoption of diagnostic, triage, and decision support software is advanced. The advanced regulatory framework, the concentration of companies, the adoption of software, and the strength of investment reinforce the leadership of the region. The combination of regulatory maturity, company concentration, adoption, and investment sustains the position of North America as the largest regional market across the forecast period.

Fastest Growing Region: Asia-Pacific

Asia-Pacific is projected to register the fastest compound annual growth rate through 2034. The region combines large and growing populations, the expansion of healthcare and digital infrastructure, the growth of artificial intelligence and digital health, and the increasing adoption of clinical software, which drives the fast growth of the market. China, Japan, India, and South Korea are the principal national markets, supported by the growth of healthcare investment and digital infrastructure, the development of artificial intelligence and digital health industries, the rising burden of chronic disease, and the increasing adoption of diagnostic and clinical software. The growth of healthcare and digital infrastructure, the development of artificial intelligence and digital health, and the adoption of clinical software enlarge the demand for software as a medical device. As healthcare and digital infrastructure expand, as artificial intelligence and digital health develop, and as clinical software is adopted, the region increases its adoption from a growing base, and the scale of the population and the growth of digital health create substantial long-term demand. The combination of population scale, infrastructure expansion, artificial intelligence and digital health growth, and software adoption positions Asia-Pacific as the fastest-growing regional market, and it attracts investment and commercial focus from the leading global and regional companies.

Regional Commentary

North America

North America leads the market, supported by the advanced regulatory framework for software and artificial intelligence, the concentration of clinical artificial intelligence and digital health companies, the advanced adoption of clinical software, and the strength of research and investment. The United States dominates the region through the Food and Drug Administration framework for software and artificial intelligence, the authorization of artificial intelligence-enabled devices, and the concentration of companies. The advanced ecosystem and adoption sustain demand.

Europe

Europe is a substantial market shaped by the regulation of software under the European Union Medical Device Regulation, which classifies standalone software with a medical purpose as a medical device, the adoption of clinical software, and the presence of medical technology and digital health companies. Germany, the United Kingdom, France, Italy, and Spain are the principal national markets, supported by the adoption of clinical artificial intelligence and digital health, the regulation of software as a medical device, and the emerging artificial intelligence regulation. Demand is sustained by the adoption of diagnostic and clinical software and the growth of digital health.

Asia-Pacific

Asia-Pacific is the fastest-growing region, driven by large and growing populations, the expansion of healthcare and digital infrastructure, the growth of artificial intelligence and digital health, and the increasing adoption of clinical software across China, Japan, India, and South Korea. Infrastructure expansion, artificial intelligence and digital health growth, and software adoption sustain rapid growth, and the region attracts commercial focus from the leading global and regional companies.

Rest of World

The Rest of World, spanning Latin America, the Middle East, and Africa, represents an emerging opportunity as healthcare and digital infrastructure expand and as clinical software is adopted. Growth is supported by the growth of digital health, the adoption of diagnostic and clinical software, and the expansion of access, though adoption and regulatory maturity vary by market. Companies pursue these markets through cloud-delivered software suited to expanding digital health.

Software as a Medical Device (SaMD) Market Competitive Landscape

The global software as a medical device market is classified as Fragmented. A large and diverse group of participants competes across the categories of software as a medical device, including medical technology and imaging companies, clinical artificial intelligence specialists, digital therapeutics companies, and health technology companies, and no single participant holds a dominant share of the diverse and rapidly evolving market. Competition centers on the clinical performance and validation of the software, the regulatory clearance and pathway, the integration with clinical workflow and systems, the breadth of clinical applications, the intelligence of the artificial intelligence, reimbursement, and clinical adoption; clearances, launches, and investment intensify the contest. The competitive landscape is evaluated across the following dimensions:

  • Market concentration: Fragmented, with medical technology and imaging companies, clinical artificial intelligence specialists, digital therapeutics companies, and health technology companies, and no single participant holding a dominant share of the diverse and rapidly evolving market.
  • Leading players: Philips, Siemens Healthineers, GE HealthCare, and Medtronic lead among the medical technology and imaging companies; Aidoc, Viz.ai, Digital Diagnostics, and HeartFlow lead in clinical artificial intelligence, and Cognoa, Huma, and digital therapeutics companies contest the treatment and platform categories.
  • Geographic reach: The medical technology and imaging companies operate globally, and clinical artificial intelligence and digital therapeutics specialists expand from their home markets, with concentration in North America and Europe.
  • Product portfolio strength: Competitive advantage rests on the clinical performance and validation of the software, the breadth of clinical applications, the integration with imaging and clinical systems, and the intelligence and adaptability of the artificial intelligence.
  • Pipeline strength: Development is concentrated in artificial intelligence diagnostic and triage software, digital therapeutics, clinical decision support, and the expansion of clinical applications and indications.
  • Strategic partnerships: Collaboration spans integration with imaging and electronic health record systems, partnerships with health systems and pharmaceutical companies, and alliances that extend clinical validation, distribution, and reimbursement.
  • M&A activity: Consolidation has shaped the field, with medical technology and imaging companies acquiring clinical artificial intelligence and software companies and platforms consolidating clinical artificial intelligence, alongside continued investment and consolidation.
  • Innovation focus: Innovation is shifting toward advanced artificial intelligence diagnostic and triage software, digital therapeutics, adaptive and learning algorithms with change control, and the integration and platforming of clinical software.
  • Regulatory standing: Clearance and authorization by the Food and Drug Administration, conformity under the European Union Medical Device Regulation, alignment with the International Medical Device Regulators Forum framework, and the adoption of the predetermined change control plan for adaptive software are decisive competitive credentials and a principal axis of competition among the leaders.

Software as a Medical Device (SaMD) Market Recent Developmental Activities

In 2021, the Food and Drug Administration published its artificial intelligence and machine learning software as a medical device action plan, setting out a framework for the oversight of artificial intelligence and machine learning-based software. Strategic significance: the action plan advanced the tailored regulation of artificial intelligence software and shaped the development of subsequent guidance.

In June 2023, Huma Therapeutics Limited received Food and Drug Administration Class II clearance for a disease-agnostic software as a medical device platform, enabling the configuration of regulated software across conditions. Strategic significance: the clearance advanced the platform model of software as a medical device and enabled the rapid configuration of regulated software.

Software as a Medical Device (SaMD) Market Segmentation

Software as a Medical Device (SaMD) Market Assessment by Type

  • Diagnostic and Screening Software
  • Clinical Decision Support Software
  • Digital Therapeutics
  • Monitoring and Treatment Planning Software

Software as a Medical Device (SaMD) Market Assessment by Application

  • Radiology and Medical Imaging
  • Cardiology
  • Neurology
  • Ophthalmology
  • Others

Software as a Medical Device (SaMD) Market Assessment by Deployment

  • Cloud-Based
  • On-Premise and Embedded

Software as a Medical Device (SaMD) Market Assessment by End-User

  • Hospitals and Clinics
  • Patients and Consumers
  • Diagnostic and Imaging Centers
  • Others

Software as a Medical Device (SaMD) Market Assessment by Geography

  • North America
  • United States Software as a Medical Device Market Size in USD million (2023-2034)
  • Canada Software as a Medical Device Market Size in USD million (2023-2034)
  • Mexico Software as a Medical Device Market Size in USD million (2023-2034)
  • Europe
  • Germany Software as a Medical Device Market Size in USD million (2023-2034)
  • United Kingdom Software as a Medical Device Market Size in USD million (2023-2034)
  • France Software as a Medical Device Market Size in USD million (2023-2034)
  • Italy Software as a Medical Device Market Size in USD million (2023-2034)
  • Spain Software as a Medical Device Market Size in USD million (2023-2034)
  • Rest of Europe Software as a Medical Device Market Size in USD million (2023-2034)
  • Asia-Pacific
  • China Software as a Medical Device Market Size in USD million (2023-2034)
  • Japan Software as a Medical Device Market Size in USD million (2023-2034)
  • India Software as a Medical Device Market Size in USD million (2023-2034)
  • Australia Software as a Medical Device Market Size in USD million (2023-2034)
  • South Korea Software as a Medical Device Market Size in USD million (2023-2034)
  • Rest of Asia-Pacific Software as a Medical Device Market Size in USD million (2023-2034)
  • Rest of the World
  • Middle East Software as a Medical Device Market Size in USD million (2023-2034)
  • Africa Software as a Medical Device Market Size in USD million (2023-2034)
  • South America Software as a Medical Device Market Size in USD million (2023-2034)

Key Takeaways from the Software as a Medical Device (SaMD) Market Report Study

  • Market size analysis for the current software as a medical device market size (2025), and market forecast for 9 years (2026 to 2034).
  • Top key software, artificial intelligence, and regulatory developments, clearances, partnerships, and investments that happened over the last 3 years.
  • Key companies dominating the global software as a medical device market.
  • Various opportunities available for competitors in the software as a medical device market space.
  • What are the top-performing segments in 2025? How will these segments perform in 2034?
  • Which are the top-performing regions and countries in the current software as a medical device market scenario?
  • Which are the regions and countries where companies should concentrate their opportunities for software as a medical device market growth in the future?

Target audience who can benefit from this software as a medical device market report study

  • Software as a medical device, clinical artificial intelligence, and digital therapeutics providers
  • Research organizations and consulting companies
  • Software as a medical device-related organizations, associations, forums, and other alliances
  • Government and corporate offices
  • Start-up companies, venture capitalists, and private equity firms
  • Hospitals, health systems, and medical technology companies dealing in clinical software
  • Various end-users who want to know more about the software as a medical device market and the latest technological developments in the software as a medical device market.

Frequently Asked Questions:

Q1. At what rate is the software as a medical device market expected to grow?

The global software as a medical device market is projected to grow at a compound annual growth rate of 17.4% during the forecast period from 2026 to 2034.

Q2. What is the current and projected size of the software as a medical device market?

The global software as a medical device market was valued at USD 2.10 billion in 2025 and is projected to reach USD 8.90 billion by 2034.

Q3. Which region dominates the software as a medical device market?

North America dominated the software as a medical device market with a 45% share in 2025, driven by the advanced regulatory framework for software and artificial intelligence, the concentration of clinical artificial intelligence and digital health companies, the advanced adoption of clinical software, and the strength of research and investment, with the Food and Drug Administration having authorized a large and growing number of artificial intelligence-enabled devices. Asia-Pacific is projected to record the fastest compound annual growth rate through 2034, driven by the expansion of healthcare and digital infrastructure and the growth of artificial intelligence and digital health across China, Japan, India, and South Korea.

Q4. What are the key factors driving growth in the software as a medical device market?

The principal drivers are the integration of artificial intelligence and machine learning into clinical software; the growth of digital therapeutics and software-based treatment; the maturation of regulatory pathways for software and adaptive algorithms, including the predetermined change control plan; the demand for diagnostic and clinical decision support; the growth of remote monitoring, telehealth, and connected care; and the rising burden of chronic disease and the demand for scalable software.

Q5. Who are the major players in the software as a medical device market?

The market is fragmented and led by Koninklijke Philips N.V., Siemens Healthineers AG, GE HealthCare Technologies Inc., Medtronic plc, and Aidoc Medical Ltd., alongside Viz.ai, Inc., Digital Diagnostics Inc., HeartFlow, Inc., Cognoa, Inc., and Huma Therapeutics Limited. Additional participants, including Cleerly, Inc., Paige.AI, Inc., and RapidAI, compete across clinical artificial intelligence, imaging, and digital therapeutics software.

Table of Contents

1. Introduction

  • 1.1. Scope of the Report
  • 1.2. Market Segmentation
  • 1.3. Market Overview at a Glance

2. Executive Summary of Software as a Medical Device (SaMD) Market

  • 2.1. Key Highlights and Market Snapshot

3. Key Factors Impacting the Software as a Medical Device (SaMD) Market

  • 3.1. Market Drivers
    • 3.1.1. Integration of Artificial Intelligence and Machine Learning into Clinical Software
    • 3.1.2. Growth of Digital Therapeutics and Software-Based Treatment
    • 3.1.3. Maturation of Regulatory Pathways for Software and Adaptive Algorithms
    • 3.1.4. Diagnostic Support, Connected Care, and Scalable Software
  • 3.2. Market Restraints
    • 3.2.1. Regulatory Complexity and Adaptive Algorithm Challenges
    • 3.2.2. Reimbursement and Clinical Validation Constraints
    • 3.2.3. Clinical Adoption, Integration, and Liability
  • 3.3. Market Opportunities
    • 3.3.1. Artificial Intelligence, Digital Therapeutics, and Adaptive Software
    • 3.3.2. Emerging Markets and Connected Care

4. Impact Analysis: AI, Geopolitical, Trade, and Economic Developments

5. Regulatory Analysis

  • 5.1. The United States
  • 5.2. Europe
  • 5.3. Japan
  • 5.4. China

6. Porter's Five Forces Analysis

  • 6.1. Bargaining Power of Suppliers
  • 6.2. Bargaining Power of Consumers
  • 6.3. Threat of New Entrants
  • 6.4. Threat of Substitutes
  • 6.5. Competitive Rivalry

7. Software as a Medical Device (SaMD) Market Assessment

  • 7.1. By Type
    • 7.1.1. Diagnostic and Screening Software
    • 7.1.2. Clinical Decision Support Software
    • 7.1.3. Digital Therapeutics
    • 7.1.4. Monitoring and Treatment Planning Software
  • 7.2. By Application
    • 7.2.1. Radiology and Medical Imaging
    • 7.2.2. Cardiology
    • 7.2.3. Neurology
    • 7.2.4. Ophthalmology
    • 7.2.5. Others
  • 7.3. By Deployment
    • 7.3.1. Cloud-Based
    • 7.3.2. On-Premise and Embedded
  • 7.4. By End-User
    • 7.4.1. Hospitals and Clinics
    • 7.4.2. Patients and Consumers
    • 7.4.3. Diagnostic and Imaging Centers
    • 7.4.4. Others
  • 7.5. By Geography
    • 7.5.1. North America
      • 7.5.1.1. United States Software as a Medical Device Market Size in USD million (2023-2034)
      • 7.5.1.2. Canada Software as a Medical Device Market Size in USD million (2023-2034)
      • 7.5.1.3. Mexico Software as a Medical Device Market Size in USD million (2023-2034)
    • 7.5.2. Europe
      • 7.5.2.1. Germany Software as a Medical Device Market Size in USD million (2023-2034)
      • 7.5.2.2. United Kingdom Software as a Medical Device Market Size in USD million (2023-2034)
      • 7.5.2.3. France Software as a Medical Device Market Size in USD million (2023-2034)
      • 7.5.2.4. Italy Software as a Medical Device Market Size in USD million (2023-2034)
      • 7.5.2.5. Spain Software as a Medical Device Market Size in USD million (2023-2034)
      • 7.5.2.6. Rest of Europe Software as a Medical Device Market Size in USD million (2023-2034)
    • 7.5.3. Asia-Pacific
      • 7.5.3.1. China Software as a Medical Device Market Size in USD million (2023-2034)
      • 7.5.3.2. Japan Software as a Medical Device Market Size in USD million (2023-2034)
      • 7.5.3.3. India Software as a Medical Device Market Size in USD million (2023-2034)
      • 7.5.3.4. Australia Software as a Medical Device Market Size in USD million (2023-2034)
      • 7.5.3.5. South Korea Software as a Medical Device Market Size in USD million (2023-2034)
      • 7.5.3.6. Rest of Asia-Pacific Software as a Medical Device Market Size in USD million (2023-2034)
    • 7.5.4. Rest of the World
      • 7.5.4.1. Middle East Software as a Medical Device Market Size in USD million (2023-2034)
      • 7.5.4.2. Africa Software as a Medical Device Market Size in USD million (2023-2034)
      • 7.5.4.3. South America Software as a Medical Device Market Size in USD million (2023-2034)

8. Software as a Medical Device (SaMD) Market Competitive Landscape

  • 8.1. Competitive Analysis
  • 8.2. Company Share Analysis (Premium Offering)

9. Software as a Medical Device (SaMD) Market Startup Funding and Investment Trends

10. Company and Product Profiles

  • 10.1. Koninklijke Philips N.V.
    • 10.1.1. Company Overview
    • 10.1.2. Company Snapshot
    • 10.1.3. Financial Overview
    • 10.1.4. Product Portfolio
    • 10.1.5. Strategic Initiatives / Entropy
  • 10.2. Siemens Healthineers AG
    • 10.2.1. Company Overview
    • 10.2.2. Company Snapshot
    • 10.2.3. Financial Overview
    • 10.2.4. Product Portfolio
    • 10.2.5. Strategic Initiatives / Entropy
  • 10.3. GE HealthCare Technologies Inc.
    • 10.3.1. Company Overview
    • 10.3.2. Company Snapshot
    • 10.3.3. Financial Overview
    • 10.3.4. Product Portfolio
    • 10.3.5. Strategic Initiatives / Entropy
  • 10.4. Medtronic plc
    • 10.4.1. Company Overview
    • 10.4.2. Company Snapshot
    • 10.4.3. Financial Overview
    • 10.4.4. Product Portfolio
    • 10.4.5. Strategic Initiatives / Entropy
  • 10.5. Aidoc Medical Ltd.
    • 10.5.1. Company Overview
    • 10.5.2. Company Snapshot
    • 10.5.3. Financial Overview
    • 10.5.4. Product Portfolio
    • 10.5.5. Strategic Initiatives / Entropy
  • 10.6. Viz.ai, Inc.
    • 10.6.1. Company Overview
    • 10.6.2. Company Snapshot
    • 10.6.3. Financial Overview
    • 10.6.4. Product Portfolio
    • 10.6.5. Strategic Initiatives / Entropy
  • 10.7. Digital Diagnostics Inc.
    • 10.7.1. Company Overview
    • 10.7.2. Company Snapshot
    • 10.7.3. Financial Overview
    • 10.7.4. Product Portfolio
    • 10.7.5. Strategic Initiatives / Entropy
  • 10.8. HeartFlow, Inc.
    • 10.8.1. Company Overview
    • 10.8.2. Company Snapshot
    • 10.8.3. Financial Overview
    • 10.8.4. Product Portfolio
    • 10.8.5. Strategic Initiatives / Entropy
  • 10.9. Cognoa, Inc.
    • 10.9.1. Company Overview
    • 10.9.2. Company Snapshot
    • 10.9.3. Financial Overview
    • 10.9.4. Product Portfolio
    • 10.9.5. Strategic Initiatives / Entropy
  • 10.10. Huma Therapeutics Limited
    • 10.10.1. Company Overview
    • 10.10.2. Company Snapshot
    • 10.10.3. Financial Overview
    • 10.10.4. Product Portfolio
    • 10.10.5. Strategic Initiatives / Entropy

For illustrative purposes, only the top 10 companies are listed in the Table of Contents. The report may include analysis and references to additional companies where relevant to the market assessment.

11. KOL Views

12. Project Approach

13. About DelveInsight

14. Disclaimer and Contact Us

List of Tables

  • Table 1: Global Software as a Medical Device Market Size in USD million (2023-2034)
  • Table 2: Global Software as a Medical Device Market Size by Type in USD million (2023-2034)
  • Table 3: Global Software as a Medical Device Market Size by Application in USD million (2023-2034)
  • Table 4: Global Software as a Medical Device Market Size by Deployment in USD million (2023-2034)
  • Table 5: Global Software as a Medical Device Market Size by End-User in USD million (2023-2034)
  • Table 6: Software as a Medical Device Market Size in North America in USD million (2023-2034)
  • Table 7: Software as a Medical Device Market Size in the United States in USD million (2023-2034)
  • Table 8: Software as a Medical Device Market Size in Canada in USD million (2023-2034)
  • Table 9: Software as a Medical Device Market Size in Mexico in USD million (2023-2034)
  • Table 10: Software as a Medical Device Market Size in Europe in USD million (2023-2034)
  • Table 11: Software as a Medical Device Market Size in Germany in USD million (2023-2034)
  • Table 12: Software as a Medical Device Market Size in the United Kingdom in USD million (2023-2034)
  • Table 13: Software as a Medical Device Market Size in France in USD million (2023-2034)
  • Table 14: Software as a Medical Device Market Size in Italy in USD million (2023-2034)
  • Table 15: Software as a Medical Device Market Size in Spain in USD million (2023-2034)
  • Table 16: Software as a Medical Device Market Size in the Rest of Europe in USD million (2023-2034)
  • Table 17: Software as a Medical Device Market Size in Asia-Pacific in USD million (2023-2034)
  • Table 18: Software as a Medical Device Market Size in China in USD million (2023-2034)
  • Table 19: Software as a Medical Device Market Size in Japan in USD million (2023-2034)
  • Table 20: Software as a Medical Device Market Size in India in USD million (2023-2034)
  • Table 21: Software as a Medical Device Market Size in Australia in USD million (2023-2034)
  • Table 22: Software as a Medical Device Market Size in South Korea in USD million (2023-2034)
  • Table 23: Software as a Medical Device Market Size in the Rest of Asia-Pacific in USD million (2023-2034)
  • Table 24: Software as a Medical Device Market Size in the Rest of the World in USD million (2023-2034)
  • Table 25: Software as a Medical Device Market Size in the Middle East in USD million (2023-2034)
  • Table 26: Software as a Medical Device Market Size in Africa in USD million (2023-2034)
  • Table 27: Software as a Medical Device Market Size in South America in USD million (2023-2034)
  • Table 28: Software as a Medical Device Market Competitive Landscape
  • Table 29: Software as a Medical Device Market Startup Funding and Investment Trends

List of Figures

  • Figure 1: Software as a Medical Device Market Drivers
  • Figure 2: Software as a Medical Device Market Restraints
  • Figure 3: Software as a Medical Device Market Opportunities
  • Figure 4: Impact Analysis: AI, Geopolitical, Trade, and Economic Developments
  • Figure 5: Regulatory Analysis of the Software as a Medical Device Market (the United States)
  • Figure 6: Regulatory Analysis of the Software as a Medical Device Market (Europe)
  • Figure 7: Regulatory Analysis of the Software as a Medical Device Market (Japan)
  • Figure 8: Regulatory Analysis of the Software as a Medical Device Market (China)
  • Figure 9: Porter's Five Forces Analysis of the Software as a Medical Device Market
  • Figure 10: Competitive Analysis of the Software as a Medical Device Market
  • Figure 11: Global Software as a Medical Device Market Size in USD million (2023-2034)
  • Figure 12: Global Software as a Medical Device Market Size by Type in USD million (2023-2034)
  • Figure 13: Global Software as a Medical Device Market Size by Application in USD million (2023-2034)
  • Figure 14: Global Software as a Medical Device Market Size by Deployment in USD million (2023-2034)
  • Figure 15: Global Software as a Medical Device Market Size by End-User in USD million (2023-2034)
  • Figure 16: Software as a Medical Device Market Size in North America in USD million (2023-2034)
  • Figure 17: Software as a Medical Device Market Size in the United States in USD million (2023-2034)
  • Figure 18: Software as a Medical Device Market Size in Canada in USD million (2023-2034)
  • Figure 19: Software as a Medical Device Market Size in Mexico in USD million (2023-2034)
  • Figure 20: Software as a Medical Device Market Size in Europe in USD million (2023-2034)
  • Figure 21: Software as a Medical Device Market Size in Germany in USD million (2023-2034)
  • Figure 22: Software as a Medical Device Market Size in the United Kingdom in USD million (2023-2034)
  • Figure 23: Software as a Medical Device Market Size in France in USD million (2023-2034)
  • Figure 24: Software as a Medical Device Market Size in Italy in USD million (2023-2034)
  • Figure 25: Software as a Medical Device Market Size in Spain in USD million (2023-2034)
  • Figure 26: Software as a Medical Device Market Size in the Rest of Europe in USD million (2023-2034)
  • Figure 27: Software as a Medical Device Market Size in Asia-Pacific in USD million (2023-2034)
  • Figure 28: Software as a Medical Device Market Size in China in USD million (2023-2034)
  • Figure 29: Software as a Medical Device Market Size in Japan in USD million (2023-2034)
  • Figure 30: Software as a Medical Device Market Size in India in USD million (2023-2034)
  • Figure 31: Software as a Medical Device Market Size in Australia in USD million (2023-2034)
  • Figure 32: Software as a Medical Device Market Size in South Korea in USD million (2023-2034)
  • Figure 33: Software as a Medical Device Market Size in the Rest of Asia-Pacific in USD million (2023-2034)
  • Figure 34: Software as a Medical Device Market Size in the Rest of the World in USD million (2023-2034)
  • Figure 35: Software as a Medical Device Market Size in the Middle East in USD million (2023-2034)
  • Figure 36: Software as a Medical Device Market Size in Africa in USD million (2023-2034)
  • Figure 37: Software as a Medical Device Market Size in South America in USD million (2023-2034)