FDA’s Latest Lists for Digital Health Technologies

FDA announced earlier this month that it had updated its list of artificial intelligence (AI)-enabled medical devices and created new lists for medical devices that incorporate augmented reality or virtual reality and medical devices that incorporate sensor-based digital health technology.  The list for AI-enabled devices had not been updated since September 2024, so its lack of upkeep does not appear related to changes in the FDA workforce earlier this year.

While the information within these lists has always been available through the searchable FDA databases, having the information organized into a single location may be helpful for a number of reasons.  Developers searching for a predicate device may more easily identify devices that use technology similar to their device, or more easily determine that there is not another device with the same intended use and equivalent technological characteristics, which would indicate their device is likely appropriate for a De Novo submission.  Also, given the rapid changes in these types of technology, the information and testing being requested by FDA for review of these digital health technologies may be evolving, and being able to easily find recent submission summaries from across the review divisions may be a useful resource. At a recent conference, we heard from clinicians that it was often difficult for them to find information on the performance of medical device software that incorporates AI, so being able to easily locate devices of interest may especially be helpful for health care professionals to find summary information of the types of testing FDA reviewed and performance of the AI-models.

The lists include the date of FDA’s final decision, submission number, device name, company name, lead review panel (e.g., radiology or cardiovascular), and primary product code.  They provide a search bar to help find specific products and also include options to download the data to a CSV, Excel, or XML file.

We did some analyses of the lists and learned the following.

AI-enabled devices

There are 1,247 AI-enabled devices on the list, with the earliest approvals dating back to 1995.  As you might imagine, in the early years, there were few AI-enabled devices, with a total of 10 AI-enabled devices authorized in the first ten years.  In contrast, 253 AI-enabled devices were authorized in 2024 alone.  There have been 1,195 (96%) AI-enabled devices authorized via 510(k) clearance, 36 (3%) AI-enabled devices authorized via De Novos, and 16 (1%) AI-enabled devices authorized via premarket approval (PMA).

Of the 1,247 AI-enabled devices, 956 (77%) were authorized by the radiology panel and 116 (9%) by the cardiovascular panel.  The number of AI-enabled device submissions across the other review divisions is quite sparse with the neurology, anesthesiology, hematology, and gastroenterology-urology panels authorizing between 1% and 5% of AI-enabled devices, and the remaining panels each authorizing fewer than 1% of AI-enabled device applications.

Augmented reality/virtual reality devices

FDA’s website defines augmented reality as “a real-world augmented experience with overlaying or mixing simulated digital imagery with the real world as seen through a camera or display, such as a smartphone or head-mounted or heads-up display (HUD). Digital imagery may be able to interact with real surroundings (often controlled by users). This is sometimes referred to as mixed or merged reality.” Virtual reality is defined as “a virtual world immersive experience that may require a headset to completely replace a user’s surrounding view with a simulated, immersive, and interactive virtual environment.”

There are 92 augmented reality/virtual reality devices on the list, with the earliest submission cleared in 2015.  The radiology panel also topped review of these device types with 34 devices on the list (37%).  The orthopedic review panel authorized 25 submissions (27%), with neurology coming in third with 17 authorizations (18%).  Cardiovascular, ear, nose, and throat, general and plastic surgery, ophthalmic, and physical medicine review panels have each reviewed a small number of these device types.

Devices that incorporate sensor-based digital health technology

Sensor-based medical devices have been around for many years, but this list focuses on sensor-based digital health technology devices that are non- or minimally invasive, wearable, designed for continuous or spot check monitoring of an individual’s health parameters, and that can be used in non-clinical settings, such as the home.  As such, the list includes technologies authorized beginning in 2015.

There are 215 sensor-based digital health technology devices on the list.  Over half of these submissions (111 or 51%) were reviewed by the cardiovascular review panel.  The neurology, clinical chemistry, and anesthesiology review panels reviewed 18%, 17%, and 12%, respectively, with the ophthalmic and ear, nose, and throat review panels constituting only 1%.

The lists were updated on July 10, 2025, and do not appear to be updated daily as new devices are cleared.  We will watch to see if FDA updates the lists regularly (e.g., monthly when summary documents are added to the 510(k) database), or if it will be another nine months before the next update is made.

FDA notes that the lists may not be comprehensive, as they were generated based on the use of related terms in the summary descriptions of marketing authorization documents or the device’s classification.  FDA notes that it will explore methods to identify and tag medical devices that incorporate these technologies in the future.  Until then, users should be cautious and check other sources if the information being searched for is not found on the list.