Understanding the FDA’s searchable resources for AI, AR/VR, and Sensor-based Digital Health Technologies
Digital health technologies are changing the way medical devices are developed and used. Artificial Intelligence (AI), Software as a Medical Device (SaMD), wearable sensors, remote patient monitoring, and augmented reality applications are now part of everyday conversations in the medical device industry.
One common challenge for regulatory professionals is identifying similar FDA-authorized products. While the FDA’s 510(k), De Novo, and PMA databases have always been available, finding devices that use a particular digital health technology often requires reviewing numerous records individually.
To make this easier, the FDA maintains dedicated searchable lists for selected digital health technologies. These resources organize FDA-authorized devices into specific technology categories, making it easier to locate comparable products and understand the current regulatory landscape.
Although these lists do not introduce new regulatory requirements, they are useful resources for regulatory planning, product development, and competitive intelligence.
FDA Searchable Digital Health Device Lists
The FDA currently maintains searchable lists for three categories of digital health medical devices:
- Artificial Intelligence (AI)-Enabled Medical Devices
- Augmented Reality (AR) and Virtual Reality (VR) Medical Devices
- Sensor-based Digital Health Technology (sDHT) Medical Devices
Each list includes devices that have received FDA marketing authorization and provides direct access to publicly available regulatory information.
Artificial Intelligence (AI)-Enabled Medical Devices
The AI-Enabled Medical Devices List identifies medical devices that incorporate Artificial Intelligence and have been authorized for marketing in the United States.
Each listing includes:
- Device Name
- Manufacturer
- Submission Number
- Date of Final Decision
- Medical Specialty (Panel)
- Product Code
- Direct link to the FDA marketing authorization
The FDA has also stated that it is exploring ways to identify medical devices incorporating Foundation Models and Large Language Models (LLMs) in future updates. This will provide greater visibility into the use of advanced AI technologies in medical devices.
Official FDA AI-Enabled Medical Devices List
Augmented Reality (AR) and Virtual Reality (VR) Medical Devices
The FDA also maintains a searchable list for medical devices that incorporate Augmented Reality and Virtual Reality technologies.
These technologies are used in a wide range of clinical applications, including:
- Surgical planning and navigation
- Image-guided procedures
- Rehabilitation
- Pain management
- Mental health
- Ophthalmology
- Telemedicine
The FDA also discusses important considerations associated with these technologies, including visualization accuracy, usability, cybersecurity, privacy, and user safety.
Official FDA AR/VR Medical Devices List
Sensor-based Digital Health Technology (sDHT) Medical Devices
Healthcare delivery is steadily expanding beyond hospitals and clinics into home and community settings. Sensor-based Digital Health Technologies support this transition by enabling continuous or periodic monitoring outside traditional healthcare environments.
The FDA’s sDHT Medical Devices List focuses on devices that are generally:
- Non- or minimally invasive
- Wearable, including smartwatches, rings, patches, and bands
- Intended for continuous or spot-check monitoring
- Suitable for home or other non-clinical settings
Examples include continuous glucose monitoring systems, wearable ECG monitors, blood pressure monitoring devices, sleep monitoring systems, and remote patient monitoring technologies.
The FDA also encourages sponsors planning to incorporate digital health technologies into clinical investigations to engage early with the appropriate FDA Center.
Official FDA Sensor-based Digital Health Technology (sDHT) Medical Devices List
What Information Can You Find?
Each searchable list provides publicly available information, including:
- Date of Final Decision
- Submission Number
- Device Name
- Manufacturer
- Medical Specialty (Panel)
- Primary Product Code
Each record also links directly to the corresponding FDA marketing authorization, allowing users to review publicly available summaries for the device.
Important to Remember
The FDA notes that these lists are not comprehensive. Devices are primarily identified from information contained in publicly available marketing authorization summaries. If the use of AI, AR/VR, or sensor-based technology is not clearly described in those summaries, the device may not be included in the corresponding list.
The lists are updated periodically as additional marketing authorizations become available.
Why These Lists Matter
For medical device manufacturers, consultants, and regulatory professionals, these searchable resources provide a practical starting point when working on new products or assessing the competitive landscape.
They can be used to:
- Identify comparable FDA-authorized devices
- Review similar technologies
- Understand current trends in digital health
- Support regulatory strategy discussions
- Monitor developments across different medical specialties
Rather than replacing the FDA’s traditional databases, these technology-specific lists make it easier to focus on products that use similar digital health technologies.
MedOrdyn Perspective
At MedOrdyn Solutions, we believe regulatory intelligence is an important part of successful medical device development. Understanding how similar technologies have been authorized can help manufacturers make informed decisions during product planning, software development, risk management, clinical evaluation, and regulatory submissions.
Resources such as these FDA searchable lists provide useful insight into the current digital health landscape and can complement broader regulatory research during product development.
Conclusion
The FDA’s searchable lists for AI-enabled medical devices, AR/VR medical devices, and Sensor-based Digital Health Technologies provide a simple and practical way to explore FDA-authorized digital health products.
Whether you are developing a new device, preparing a regulatory strategy, or following developments in digital health, these resources are worth bookmarking. They make it easier to identify comparable technologies and stay informed about developments across the rapidly evolving digital health sector.
Official FDA Resources
AI-Enabled Medical Devices
Augmented Reality and Virtual Reality Medical Devices
Sensor-based Digital Health Technology (sDHT) Medical Devices
About MedOrdyn Solutions
MedOrdyn Solutions supports medical device manufacturers with regulatory affairs, quality management systems, Software as a Medical Device (SaMD), AI-enabled medical devices, IEC 62304, ISO 14971, cybersecurity, clinical and performance evaluation, and global market access across the product lifecycle.
