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The US FDA’s AI/ML-Enabled Medical Devices List includes all medical devices that incorporate artificial intelligence or machine learning and have received approval or clearance from the agency. Radiology stands out among medical specialties, accounting for the largest share of FDA-authorized devices. Siemens Medical and GE Healthcare are the leading manufacturers, holding the highest number of AI/ML-enabled devices on the list. The majority of these devices continue to be authorized through the premarket clearance (510(k)) pathway. This chapter further analyzes the public information summaries for two notable AI/ML-enabled devices cleared by the US FDA: the Sleep Apnea Notification Software as a Medical Device (SaMD) developed by Apple Inc. and the Home Optical Coherence Tomography (OCT) System by Notal Vision. The review provides detailed insights into device development, design considerations, clinical testing protocols, risk management approaches, human factors requirements, and a predetermined change control plan (PCCP), all of which are essential for meeting the US FDA’s stringent regulatory standards.

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AI-Enabled Medical Devices Approved/Cleared by the US FDA

  • 章节

  • 发表日期：

    2026年

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  • Ajit Pandey,
  • Pramod Gupta,
  • Naresh Kumar Sehgal

摘要

The US FDA’s AI/ML-Enabled Medical Devices List includes all medical devices that incorporate artificial intelligence or machine learning and have received approval or clearance from the agency. Radiology stands out among medical specialties, accounting for the largest share of FDA-authorized devices. Siemens Medical and GE Healthcare are the leading manufacturers, holding the highest number of AI/ML-enabled devices on the list. The majority of these devices continue to be authorized through the premarket clearance (510(k)) pathway. This chapter further analyzes the public information summaries for two notable AI/ML-enabled devices cleared by the US FDA: the Sleep Apnea Notification Software as a Medical Device (SaMD) developed by Apple Inc. and the Home Optical Coherence Tomography (OCT) System by Notal Vision. The review provides detailed insights into device development, design considerations, clinical testing protocols, risk management approaches, human factors requirements, and a predetermined change control plan (PCCP), all of which are essential for meeting the US FDA’s stringent regulatory standards.