FDA Provides List of AI-Enabled Devices

The Food and Drug Administration (FDA) recently published an updated list of approved/cleared Artificial Intelligence and Machine Learning (AI/ML) enabled devices that have been marketed in the United States across multiple medical specialties. These devices have met the FDA’s related premarket requirements, including a “focused review of the devices’ overall safety and effectiveness, which includes an evaluation of appropriate study diversity based on the device’s intended use and technological characteristics.” There are a total of 882 approved/cleared AI/ML enabled devices, including 191 additions. Radiology-focused companies are in the majority for these devices. The top five companies include:

  1. GE HealthCare – 72
  2. Siemens Healthineers – 64
  3. Canon – 28
  4. Philips – 27
  5. Aidoc – 23

Although the approvals/clearance of these types of devices have increased in recent years, the Centers for Medicare and Medicaid Services (CMS) has only assigned payment for about 10 of these device applications. In response, several patient advocacy groups recently requested Congress to address this issue with CMS by encouraging creation of a forized payment pathway for AI/ML devices. Known as Algorithm-Based Healthcare Services, it would be anticipated to be published in the 2025 Hospital Outpatient Prospective Payment Systems (OPPS) proposed/final rules.