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FDA已批准超1200款AI医疗器械:影像学之外,新的扩张专科在哪里?
思宇MedTech·2025-08-21 03:50

Core Viewpoint - Artificial Intelligence (AI) is rapidly penetrating the medical device field, with over 1,200 AI/ML medical devices approved by the FDA as of July 2025, including a record 235 devices approved in 2024, indicating that AI is becoming a significant part of clinical practice [2][4]. Group 1: AI in Medical Imaging - Radiology remains the dominant application area for AI, focusing on tasks such as automatic image segmentation, lesion detection, and risk screening [4]. - The cardiovascular specialty is experiencing accelerated adoption of AI, expanding from ECG rhythm analysis to cardiac ultrasound and CT coronary imaging due to the high prevalence of cardiovascular diseases and the suitability of imaging data for AI training [5][6]. Group 2: AI in Neurology - In neurology, AI's initial entry point is acute stroke image recognition, with applications including arrhythmia detection and heart failure risk prediction [7][8]. - AI systems can automatically interpret CT/MRI scans within minutes, identifying potential ischemic or hemorrhagic lesions and notifying neurologists, thus shortening the "golden hour" for treatment [9]. - Neurology is emerging as a new growth area for FDA approvals due to high-risk, high-value disease scenarios, such as the urgent need for stroke decision-making and unmet needs in epilepsy and dementia [10]. Group 3: Emerging Specialties - Other specialties, including endoscopy and pathology, are also seeing rapid growth in AI medical devices, with applications in automatic identification of polyps and early tumors during gastrointestinal examinations [12]. - AI is enhancing efficiency in pathology by automating the identification and classification of digital pathology slides, allowing pathologists to quickly locate suspicious areas [12]. Group 4: Regulatory Challenges - As the number of FDA-approved AI medical devices surpasses 1,200, regulatory challenges are emerging, particularly in keeping pace with technological advancements [11]. - The focus of FDA regulation is shifting from merely approving the number of AI devices to balancing innovation with safety, necessitating a reevaluation of regulatory frameworks as AI evolves from a "tool" to a "partner" in healthcare [11][14].