Petition Pushes FDA on AI Device Review
A new petition is urging the FDA to exempt certain AI-enabled radiology devices from premarket review. Proponents argue the current regulatory process is too slow for the pace of AI innovation. If successful, the change could speed up the deployment of new AI tools in imaging workflows but also raises questions about clinical oversight.
- The petition, submitted by Harrison.ai, specifically requests a partial exemption from the 510(k) premarket notification process for certain radiology AI software, including computer-assisted diagnostic (CADx) and medical image analyzer devices. It proposes that manufacturers with an existing 510(k) clearance could introduce expanded capabilities by adhering to robust post-market surveillance instead of filing a new 510(k). - Radiology is the medical specialty most impacted by AI innovation, accounting for nearly 80% of the more than 1,300 AI-enabled medical devices cleared by the FDA as of early 2026. The vast majority of these clearances use the 510(k) pathway, which demonstrates "substantial equivalence" to a previously approved device, rather than the more stringent Premarket Approval (PMA) process. - This regulatory push coincides with a major shift in care delivery, as outpatient imaging growth now outpaces the overall radiology market. An estimated 40% of all imaging volume is now performed in outpatient settings, driven by lower costs, patient convenience, and payer pressures. - Health systems are responding to the outpatient trend by investing in freestanding imaging centers and smaller-footprint equipment suitable for mobile trailers. Projections indicate that advanced outpatient imaging volumes, including CT and PET scans, are expected to grow by 14% over the next decade. - Reimbursement changes are a key factor driving procedures out of hospitals. Medicare's site-neutral payment policies, passed in 2015, aimed to stop hospitals from acquiring independent centers and billing their services at higher hospital outpatient rates. - The imaging provider market is undergoing significant consolidation, which could accelerate the adoption of new technologies. Between 2014 and 2023, the number of radiology practices decreased by nearly 15%, while the number of practices with 100 or more radiologists grew by almost 350%. - The global mobile imaging services market was valued at over $2 billion in 2025, with North America being the largest market. Key competitors in this space include Alliance HealthCare Services, Shared Medical Services, and Carestream Health.
