FDA Updates Lists of Medical Devices Incorporating Digital Health Technology
The U.S. Food and Drug Administration (FDA) has updated its searchable lists of medical devices incorporating digital health technologies that have been authorized for marketing in the United States.
The updated resources cover three areas of digital health technology:
- Artificial intelligence (AI)
- Augmented reality and virtual reality (AR/VR)
- Sensor-based digital health technology (sDHT)
The lists provide industry, health care professionals, patients, and other stakeholders with greater visibility into medical devices incorporating these technologies that have received FDA marketing authorization.
Artificial Intelligence-Enabled Medical Devices
FDA maintains a searchable list of Artificial Intelligence-Enabled Medical Devices authorized for marketing in the United States.
The resource allows users to review devices incorporating artificial intelligence across different medical specialties and provides links to publicly available information associated with individual marketing authorizations.
For medical device developers, the list can also provide insight into the evolving landscape of FDA-authorized AI-enabled technologies.
Augmented and Virtual Reality Medical Devices
FDA also maintains a list of authorized medical devices that incorporate augmented reality or virtual reality technologies.
AR and VR technologies may be incorporated into medical devices for a variety of applications. FDA’s searchable resource provides a centralized location for identifying devices using these technologies that have received marketing authorization.
Sensor-Based Digital Health Technologies
The third updated resource identifies authorized medical devices incorporating sensor-based digital health technology.
FDA describes these technologies as having the potential to capture information about an individual’s health, including in real time and outside traditional clinical environments.
The list includes certain non- or minimally invasive devices, including wearable technologies such as smartwatches, rings, patches, and bands, designed for continuous or spot-check monitoring of health parameters.
Important Limitation of FDA’s Lists
FDA emphasizes that these lists should not be considered comprehensive inventories of all authorized medical devices incorporating digital health technology.
Devices are identified primarily based on information provided in the summary descriptions of their marketing authorization documents.
FDA updates the lists periodically as additional devices are identified.
Why These Resources May Be Useful
For medical device manufacturers and developers, FDA’s digital health technology lists can serve as useful regulatory intelligence resources.
Reviewing authorized devices may help companies better understand the evolving medical device landscape, identify technologies receiving FDA authorization, and access publicly available information associated with individual device submissions.
The resources may be particularly relevant to companies developing devices incorporating AI, AR/VR, wearable sensors, remote monitoring technologies, and other digital health capabilities.
EAS Perspective
Digital health technologies continue to become increasingly integrated into medical device development. FDA’s searchable lists provide companies with another resource for monitoring the evolving regulatory landscape and reviewing publicly available information about authorized devices incorporating these technologies.
Developers should recognize, however, that FDA specifically states that these lists are not comprehensive. They should therefore be considered one regulatory intelligence resource rather than a complete representation of all authorized digital health medical devices.
EAS Consulting Group will continue monitoring FDA developments affecting digital health technologies and medical device regulation.
Source: FDA Update
Date: September 2026
Posted in FDA and USDA Regulatory Update, Medical Devices.