Similar to AI-based medical devices, the US regulator, the FDA has an official list of devices of augmented and virtual reality too.
Just as a quick reminder, Virtual Reality (VR) completely shields the physical world from the user and immerses them in an interactive virtual environment. While Augmented Reality (AR) superimposes the physical environment with virtual elements that have limited interaction.
As the FDA states:
“Augmented Reality and Virtual Reality have the potential to transform health care, delivering new types of treatments and diagnostics and changing how and where care is delivered. Central to their potential in diagnosis and treatment is their ability to deliver both standard and entirely new types of content in highly immersive and realistic ways, remotely, and tailored to a variety of clinical contexts. Physicians, patients, and caregivers can enlist AR/VR to help them prepare for, or perform, certain treatments or procedures.”
The list
There are 92 devices in the list as of today. Here are the analyses based on different aspects.
Regarding which medical specialties the devices are related to:
- Radiology 34 devices
- Orthopedic 25
- Neurology 17
- Physical Medicine 7
- Ophthalmic 4
Regarding when the devices got approved, there is a slow increase over the years:
- 2015 1
- 2016 4
- 2017 4
- 2018 3
- 2019 7
- 2020 5
- 2021 12
- 2022 14
- 2023 19
- 2024 16
- 2025 August 7
Regarding submission type, 90 devices have received approvals as the 510(k) submission type, with only two devices being cleared through the De Novo process.
And regarding companies that submitted the applications, here are the ones with multiple approvals or clearances:
- Medacta International S.A. 8
- Pixee Medical 5
- Surgical Theater, Inc. 5
- Augmedics Ltd. 5
- Ceevra, Inc. 4
As always, we will keep a close eye on such developments and reanalyze the list as soon as updates are available.
Conclusions
While this list is not even comparable to that of AI-based medical devices, it sets a great example for other policy-makers and regulators to make their official lists public. The FDA is leading the race in this aspect worldwide. Companies working on VR and AR applications could get a better picture of what use cases and real-life clinical or patient needs could overcome the hurdles of regulations better.
The post What Can We Learn From The FDA’s List of Augmented and Virtual Reality Devices? appeared first on The Medical Futurist.