Comprehensive Market Analysis Based on FDA 510(k) Approvals
Report Period: 2018 - 2025 | Total AI Devices Analyzed: 150+
This comprehensive analysis examines the leading companies in AI medical devices based on FDA approvals across all artificial intelligence-related product codes. The results reveal a dynamic market where specialized emergency care AI dominates, with Aidoc Medical leading with 29 AI devices, followed by established imaging giants and innovative AI-native companies. The market shows strong specialization in emergency care, stroke detection, and breast cancer screening, with significant international participation representing 60% of the top companies.
Market Focus: Emergency radiology AI, critical care detection, hospital workflow automation
Market Focus: Enterprise medical imaging, cardiac AI, stroke detection, imaging ecosystem integration
Market Focus: Multi-specialty AI across neurology, chest imaging, oncology, comprehensive AI suite
Market Focus: Stroke care AI, emergency neurology, real-time critical care for time-sensitive conditions
Market Focus: Multi-organ AI detection, trauma imaging, fracture detection and trauma care
60% of top companies focus on emergency and critical care AI, reflecting urgent clinical need for rapid diagnosis in time-sensitive conditions like stroke and trauma.
Leading companies utilize multiple AI product codes, indicating comprehensive platforms rather than single-purpose tools. Average of 3.2 product codes per top company.
Strong international representation with 60% non-US companies, showing AI medical device innovation is truly global with leadership from Israel, Netherlands, and Taiwan.
Companies focusing on specific medical specialties show stronger device approval rates and market penetration than generalist approaches.
Aidoc Medical dominates with 29 devices across emergency care, establishing clear leadership in the AI medical device space through comprehensive emergency radiology solutions.
Multi-organ AI platforms are replacing single-purpose tools, with real-time critical care detection becoming the standard for emergency departments worldwide.
AI extends beyond diagnostics into therapy with companies like Cala Health pioneering AI-controlled treatment devices for neurological conditions.
Companies like Qure.ai demonstrate AI's potential for addressing healthcare challenges in developing markets, particularly for tuberculosis and emergency care.
Leading platforms emphasize seamless integration with existing hospital workflows, reducing implementation barriers and accelerating adoption.
High FDA approval rates across multiple product codes indicate mature technology and well-established regulatory pathways for AI medical devices.
Report compiled from FDA CDRH 510(k) database analyzing all AI-related product codes through 2025.
Data Sources: FDA 510(k) Approvals Database | Analysis Period: 2018-2025 | Last Updated: August 2025