Artificial intelligence continues to reshape healthcare, and radiology remains at the forefront of that transformation. As of July 10, 2025, the U.S. Food and Drug Administration (FDA) has added over 100 new AI-enabled radiology tools to its list of cleared medical devices. This marks the first update to the FDA’s public list of AI devices this year and reflects the accelerating pace of innovation in medical imaging.
With 146 newly approved AI applications since January, radiology once again leads all clinical categories. Of those, 115 are specific to radiology alone, bringing the total number of cleared radiology AI tools to 873. When factoring in imaging-related tools within cardiology, neurology, and orthopedics, that number likely exceeds 1,000 (FDA, 2025a).
Radiology at the Center of AI Growth
Radiology’s reliance on high-resolution imaging and digital workflows makes it a natural match for AI integration. AI algorithms can assist with image interpretation, detect abnormalities, and reduce diagnostic delays—functions that help radiologists manage increasing workloads without compromising accuracy. The surge in FDA clearances indicates both clinical demand and regulatory confidence in these tools.
Notable recent approvals have been granted to major medical technology companies, including Aidoc, Hyperfine, Clairity, GE HealthCare, Philips, Fujifilm, Canon Medical Systems, and Annalise.AI. These companies are developing tools that support a wide range of clinical needs, from stroke detection to lung nodule analysis, and cardiac plaque assessment (Health Imaging, 2025).
From Approval to Implementation
While the volume of FDA-cleared devices continues to grow, reimbursement remains a significant hurdle. As of now, only a limited number of AI applications are eligible for payment under public and private health plans. However, recent developments suggest that this may soon change.
In October 2024, the Centers for Medicare and Medicaid Services (CMS) updated its policies to allow reimbursement for AI-supported coronary plaque assessments when used in conjunction with coronary CT angiography (CCTA). CMS determined that these tools are “reasonable and medically necessary” when used in appropriate patients (CMS, 2024). This decision marks a critical step forward and may set a precedent for future coverage of AI-enabled diagnostics.
Looking Ahead
As AI adoption increases, healthcare organizations must carefully assess which tools deliver measurable clinical value and align with regulatory and reimbursement frameworks. FDA approval is only the beginning—true impact comes from thoughtful integration into workflows, appropriate training, and validation within each organization’s specific clinical environment.
Radiology departments in particular should stay informed of emerging AI tools and evaluate their relevance based on factors such as diagnostic performance, workflow fit, and compatibility with existing systems. In parallel, policy shifts like CMS’s reimbursement updates should be monitored closely, as they will shape the long-term return on investment for AI adoption.
At EMMA International, we help healthcare and life sciences organizations understand how to navigate this fast-evolving regulatory space. From FDA submission strategy to post-market compliance and reimbursement readiness, our team is here to support your innovation journey.
For more information on how EMMA International can assist, visit www.emmainternational.com. Contact EMMA International at (248) 987-4497 or by email at info@emmainternational.com to learn more.
References
CMS (2024). “National Coverage Determination for Artificial Intelligence-Assisted Coronary Plaque Assessment.” Centers for Medicare and Medicaid Services. Available at: https://www.cms.gov
FDA (2025a). “Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices.” U.S. Food and Drug Administration. Available at: https://www.fda.gov
Health Imaging (2025). “Over 100 AI-enabled radiology algorithms added to FDA’s list of approvals.” Health Imaging. Available at: https://www.healthimaging.com
