AI Imaging Tools See Flurry of FDA Clearances
Several AI-powered imaging software tools have recently received FDA clearance. These include Sonio Detect for fetal ultrasound quality assurance, Zebra Medical Vision’s first oncology tool for mammography, and Positrigo’s NeuroLF Brain PET system for diagnosing multiple brain disorders. Additionally, CureMetrix’s cmAngio received clearance for detecting cardiovascular risk from mammograms, enabling dual-use screening.
- The number of AI-enabled medical devices cleared by the FDA has grown exponentially, with radiology accounting for the vast majority of these tools. As of May 2025, the FDA had authorized 956 AI-enabled radiology products, representing 77% of all such medical device clearances. - Leading equipment manufacturers like GE HealthCare, Siemens Healthineers, and Philips are also major players in AI, having the highest number of FDA-cleared radiology AI tools. GE HealthCare leads with 96 authorizations, followed by Siemens Healthineers with 80. - Beyond diagnostics, AI is being integrated into radiology workflows to automate routine tasks, triage urgent cases, and improve operational efficiency. A study on AI for lung nodule detection showed a 23% improvement in efficiency for tracking patients with multiple nodules. - The American College of Radiology (ACR) is actively developing guidelines to ensure the safe and effective use of AI in imaging. The ACR's Data Science Institute is creating a framework for AI use cases, interoperability standards, and the evaluation of algorithms. - A significant shift of imaging services from hospitals to outpatient settings is underway, driven by payers and CMS policies aimed at reducing costs. This trend could reduce annual healthcare spending by over $100 billion. - In response to site-of-care shifts, health systems are expanding their freestanding imaging footprints through acquisitions, joint ventures, and building new facilities. This has fueled a wave of consolidation, with private equity firms acquiring 151 radiology practices between 2013 and 2023. - Reimbursement changes, such as site-neutral payment policies from CMS, are accelerating the move to outpatient imaging by paying lower rates for services performed in hospital outpatient departments compared to freestanding centers. - The mobile imaging services market is experiencing robust growth, projected to reach $4.16 billion by 2033, driven by the demand for accessible and cost-effective diagnostics, especially for an aging population with chronic diseases.
