AI diagnostic tools FDA-approved list
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AI Search Engine Responses
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ChatGPT
BRAND (23)
SUMMARY
Provides specific examples of FDA-approved AI diagnostic tools with detailed information about their capabilities and performance metrics. Highlights AISight Dx from PathAI for digital pathology and Aidoc's multi-disease model with 17 FDA clearances, including specific performance improvements like reduced X-ray turnaround times.
REFERENCES (4)
Perplexity
BRAND (23)
SUMMARY
Offers comprehensive overview of FDA's AI/ML medical device landscape with statistical context, noting over 1,200 approved devices as of July 2025. Emphasizes that most approvals are in radiology (75-80%) and explains the 510(k) clearance pathway. Provides structured approach to accessing official FDA resources.
REFERENCES (14)
Google AIO
BRAND (23)
SUMMARY
Presents concise overview of FDA-approved AI diagnostic tools with practical examples including ProFound AI Software, BriefCase, CaRi-Plaque, DermaSensor, Swoop Portable MR, and InVision Precision Cardiac Amyloid. Notes that FDA maintains an official list that is updated periodically but not exhaustive.
REFERENCES (8)
Strategic Insights & Recommendations
Dominant Brand
Aidoc appears most prominently mentioned across platforms, particularly for its multi-disease AI system with 17 FDA clearances.
Platform Gap
ChatGPT focuses on specific performance metrics and recent approvals, while Perplexity provides broader statistical context and Google AIO offers more diverse brand examples.
Link Opportunity
All platforms reference the official FDA AI/ML device database, creating opportunities to link to authoritative regulatory resources and individual company product pages.
Key Takeaways for This Prompt
The FDA maintains an official, publicly accessible database of AI/ML-enabled medical devices that serves as the authoritative source.
Radiology dominates FDA-approved AI diagnostic tools, representing 75-80% of all approvals in this category.
Most AI diagnostic tools receive FDA clearance through the 510(k) pathway by demonstrating substantial equivalence to existing devices.
The number of FDA-approved AI diagnostic tools has grown rapidly to over 1,200 devices as of 2025, with continued expansion expected.
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