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Industry Landscape
The medical imaging AI industry is rapidly expanding, driven by advancements in artificial intelligence and increasing demand for improved diagnostic accuracy and surgical precision. Focus on real-time imaging and integration into operating rooms is a key trend, with significant investment in innovation and clinical validation.
Total Assets Under Management (AUM)
Medical Imaging AI Market Size (USD) in United States
~2.8 billion USD (2023)
(30.9% CAGR)
- Rapid adoption in diagnostics.
- Increasing integration in surgical procedures.
- Growing demand for AI-powered image analysis.
Total Addressable Market
10.5 billion USD
Market Growth Stage
Pace of Market Growth
Emerging Technologies
Generative AI for Medical Image Synthesis
Generative AI can create synthetic medical images for training robust AI models, especially useful for rare disease detection or data augmentation when real datasets are limited.
Quantum Computing in Medical Imaging
Quantum computing has the potential to revolutionize image processing, enabling faster and more complex analyses of medical data, and accelerating drug discovery and personalized medicine.
Explainable AI (XAI)
XAI provides transparency into AI's decision-making processes, which is crucial for building trust and facilitating adoption in clinical settings where accountability and interpretability are paramount.
Impactful Policy Frameworks
FDA Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan (2021)
This FDA plan outlines a framework for the regulation of AI/ML-based SaMD, focusing on a total product lifecycle approach to ensure safety and effectiveness from premarket review to postmarket surveillance.
This policy provides a clearer regulatory pathway for AI-enabled medical devices like Perimeter's, potentially streamlining their approval process and ensuring ongoing performance monitoring.
Proposed Rule: Clinical Laboratory Improvement Amendments (CLIA) Program - Regulation of Laboratory Developed Tests (2023)
The Centers for Medicare & Medicaid Services (CMS) proposed rule aims to clarify the regulation of laboratory developed tests (LDTs), many of which are incorporating AI and advanced imaging technologies, under CLIA.
While primarily for labs, this could influence how AI-driven diagnostic components of imaging systems are used or interpreted if they generate results akin to LDTs, potentially requiring additional compliance for Perimeter's technology.
Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence (2023)
This broad executive order directs various federal agencies to set standards for AI safety, security, and ethical use across critical sectors, including healthcare, emphasizing data privacy and consumer protection.
This executive order will likely lead to more stringent requirements for data privacy, cybersecurity, and algorithmic bias testing for all AI medical devices, including Perimeter's, ensuring responsible AI development and deployment.
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