North America Artificial Intelligence (AI) in Medical Diagnostics Market By Application (Imaging Diagnostics, Genomic Diagnostics, Laboratory Diagnostics, Preventive Diagnostics, and Clinical Decision Support), By Disease (Oncology, Cardiovascular Diseases, Neurological Disorders, Respiratory Diseases, Diabetes, Infectious Diseases, Others), Market Size, Segmental analysis, Country Overview, Company share analysis, Leading Company Profiles And Market Forecast, 2025 – 2035

Industry Outlook

The North America Artificial Intelligence (AI) in Medical Diagnostics market accounted for USD 0.502 Billion in 2024 and is expected to reach USD 7.9 Billion by 2035, growing at a CAGR of around 29.2% between 2025 and 2035. The North American AI in Medical Diagnostics is centered on the integration of artificial intelligence technologies to improve the diagnosis potency and speed in healthcare. Smart solutions, including machine learning and deep learning, help with medical data like images, pathology slides, genetic data, and many others to fast and accurately diagnose illnesses. This market is a result of an enhancement in artificial intelligence technology, a rise in the cost of health, and the need to diagnose diseases at an early stage. Predominantly in radiology, pathology, and oncology, the leading participants are starting to use artificial intelligence to enhance the diagnostic capabilities within the field.

Report Scope:

Market Dynamics

U.S. healthcare modernization encourages AI adoption for diagnostics improvement.

The North America AI in medical diagnostics Market is expanding due to increasing incidences of chronic diseases, a higher aged population, and the development of quicker and more accurate diagnostic apparatus. The enhanced diagnostic capabilities with large dataset scrutiny, increased detection rates, and cut-down human error can play a huge role in detection and diagnosis. The implementation of AI in healthcare is supported by the US government. To boost the use of AI in biomedical research, the NIH financed $130 million in its Bridge2AI program, emphasizing the significance of AI in changing diagnosis and treatment.

The adoption of AI helps to improve patient outcomes by enabling the implementation of tailored treatment plans and will greatly increase efficiency by reducing expenses. With regulatory bodies such as the FDA approving AI-driven diagnostic tools, the market is set for expansive development. Education systems are one of the major players in research and development in promoting novel innovations in AI-enabled healthcare.

HIPAA regulations limit AI data-sharing and diagnostics implementation growth. 

North America AI in medical diagnostics market expansion is restricted due to the HIPAA Regulations, which set stringent guidelines for the management and exchange of patient diagnosis.  This categorization guarantees that vast and extensive datasets are not dependent on availability for efficient AI system training and validation. This has an impact on the effectiveness and quality of diagnostic algorithms, which poses significant challenges for AI developers trying to gather adequate clinical data. The healthcare market deals with higher operating costs and complexity in complying with HIPAA regulations, which could postpone the application of cutting-edge AI technology. Larger organizations with enough cash to overcome regulatory obstacles have an advantage over smaller ones by cooperating through effective data protection measures.

Collaborations with U.S. universities advance AI-driven healthcare diagnostics research.

Collaborations with U.S. universities represent an excellent opportunity to develop North America Artificial Intelligence (AI) in the medical diagnostics market. The academic institution is at the leading edge of research, functioning to develop advanced AI-driven diagnostic tools. This partnership allows such an institution to access massive clinical data, modern facilities, and high-quality professionals, which generates innovation in AI algorithms and healthcare solutions. Furthermore, universities are engaged with healthcare providers and government agencies, creating a collaborative environment for testing the translatability of research into practice. These collaborations close the feedback loop from research to industry and stimulate further advancements in diagnosis, personalized medicine, and early disease detection. They meet the necessary legal requirements and create demand at the same moment.

Industry Experts Opinion

 “We are happy with the 4th FDA nod for an additional medical solution that will leverage AI in healthcare, and improve patient care. Adding a greater number of capabilities to our Chest X-ray package is key for increasing doctors’ trust, and the use of AI.”

• Mr. Eyal Gura, Co-Founder and Chairman of Zebra Medical Vision

“We believe imaging analytics will change how we practice radiology over the next decade. Our physicians will be more productive and be enabled to create clinically actionable discrete data through the use of automated assistants that will help them deal with ever increasing workloads – without compromising quality of care.”

• Dr. Keith White, MD, medical director of imaging services at Intermountain.

Segment Analysis

Based on the application, the North America Artificial Intelligence (AI) in Medical Diagnostics market is classified into Imaging Diagnostics, Genomic Diagnostics, Laboratory Diagnostics, Preventive Diagnostics, and Clinical Decision Support. Imaging diagnostics is the dominant application segment of North America in the medical diagnostic market. This market benefits from technological advancements propelled by machine learning models to improve image interpretation from CT scans, MRIs, and X-rays.

AI has been accepted for its ability to rapidly treat diseases like cancer, cardiovascular disease, and neurology disease. This helps reduce diagnostic time, prognostic determination, and human errors due to miscalculation and fatigue. Besides, the increasing requirements for advanced diagnostic tools in healthcare appeal favorably to the segment.

Based on the disease, the North America Artificial Intelligence (AI) in Medical Diagnostics market is classified into Oncology, Cardiovascular Diseases, Neurological Disorders, Respiratory Diseases, Diabetes, Infectious Diseases, Others. The leading segment of North American AI in the medical diagnostics market is oncology. This is due to the rising use of the applications of AI technologies in the diagnosis and management of cancer, specifically breast, lung, and colorectal cancer, at their early stages.

Deep learning services are being applied to oral image analysis so that the likelihood of a radiologist detecting cancerous lesions is higher. Cardiovascular diseases experience increased growth rates caused by trends in heart diseases and the application of AI in the diagnostics of pathologies. The important adaptation areas for AI are neurological disorders and diabetes, but oncology occupies the leading position.

Regional Analysis

The North America AI in medical diagnostics market is leading in the U.S. due to healthcare digitization and the implementation of AI-based technologies. Engineering has been supported with advanced diagnostic solutions for imaging, pathology, and personalized medicine. The strong presence of big players, government support, and extensive expenditure in the North American healthcare system drive expansion in America. Rising demands for more efficient diagnostic tools ignite AI applications regarding their implementation in cancer screening, disease detection, and precision medicine.

The Canadian regional landscape for North American Artificial Intelligence (AI) in medical diagnostics is fastest growing due to healthcare innovation backed by government initiatives and research funding. Canada has utilized artificial intelligence (AI) across various domains, like absenteeism prediction and medical imaging, through partnerships with universities, tech-combat, and healthcare organizations. Its cutting-edge healthcare system and emphasis on enhancing patient outcomes, particularly in radiology and genomics, have been major factors in the adoption of AI. Furthermore, a favorable regulatory environment and an intensive talent pool in AI are the most critical factors defining the market growth.

Competitive Landscape

North American AI in the Medical Diagnostics market is highly competitive owing to numerous players introducing the markets with incredible developments. Prominent companies like Zebra Medical Vision and Arterys are modernizing medical imaging diagnostics with AI-enabled solutions to faster and more accurate disease diagnosis. The use of Butterfly Network's AI-powered portable ultrasound scanners provide real-time diagnosis at the point of treatment, is increasing. To lower the diagnostic time, Aidoc and Viz.ai have focused on AI tools that help radiologists, especially in critical conditions and stroke detection.

North America Artificial Intelligence (AI) in Medical Diagnostics Market, Company Shares Analysis, 2024

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Recent Developments:

• In February 2024, the third-generation handheld point-of-care ultrasound (POCUS) system, Butterfly iQ3, was commercially launched by Butterfly Network, Inc., a digital health company that is revolutionizing healthcare through the power of portable, semiconductor-based ultrasound technology and user-friendly software. 

Report Coverage:

By Application

• Imaging Diagnostics
• Genomic Diagnostics
• Laboratory Diagnostics
• Preventive Diagnostics
• Clinical Decision Support

By Disease

• Oncology
• Cardiovascular Diseases
• Neurological Disorders
• Respiratory Diseases
• Diabetes
• Infectious Diseases
• Others

By Region

North America

• U.S.
• Canada

List of Companies

• Zebra Medical Vision
• Arterys
• Butterfly Network
• Aidoc
• PathAI
• Viz.ai
• Proscia
• Riverain Technologies
• Enlitic
• IBM Watson Health
• Google Health (DeepMind)
• Microsoft Healthcare
• GE Healthcare
• Siemens Healthineers
• Philips Healthcare

Frequently Asked Questions (FAQs)

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