The future of AR/VR in medical devices is here

Recently, the US FDA published a list of 69 AR/VR based medical devices that are now authorized for marketing in the United States. This article presents a brief summary of innovations in this rapidly evolving field.

The difference in Augmented Reality (AR) and Virtual Reality (VR) is subtle, but important. It is useful to note that a vast majority of authorized devices are currently based on AR.

Augmented Reality, according to the FDA, is "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)".

Virtual Reality, on the other hand, provides a more "immersive experience" using a headset that completely replaces a user's surrounding view with a virtual, interactive environment.

FDA cleared the first AR/VR device in 2015, but the pace picked up only after 2019.

As shown in the figure below, there has been a rapid growth of AR/VR based medical devices in the last 5 years. AR/VR applications in medical devices have grown at an impressive CAGR of 68% from 2015-2023. At the current rate, the cumulative number of AR/VR based devices is expected to reach nearly 100 by the end of 2024.

Radiology and Orthopedic specialties account for nearly 80% of the AR/VR based devices

Neary 80% of the AR/VR medical device applications are in the Radiology and Orthopedic specialties. Other top areas of these applications are in Physical Medicine (9%), Ophthalmic (4%), and Ear, Nose and Throat (3%).

Top 2 product codes account for nearly 75% of AR/VR applications in medical devices

A closer look at the type of AR/VR applications in medical devices reveals the reason behind the heavy concentration in Radiology and Orthopedic specialties. Only 2 product codes, as shown below, account for nearly 75% of the AR/VR applications.

Top 5 companies lead the AR/VR application development with nearly 30% of devices

There are many companies actively pursuing AR/VR applications in medical devices, but the top 5 lead the category as shown in the figure below:

Examples of AR/VR devices

As an example, the ImmersiveView(TM), now in version 5, from Immersive Touch, Inc. (K210726, PRO Code LLZ) is a planning software that allows the user to visualize and interactively plan surgeries in virtual reality. It is intended for use as an image segmentation system for the transfer of imaging information, which can also be used to fabricate a physical model using traditional or additive manufacturing. An additional intended use is for precise anatomical measurements and treatment planning.

The NextAR(TM) Spine platform from Medacta International, SA (K233172, PRO Code OLO, JWH, PBF) is an augmented reality application intended to help the surgeon locate anatomical structures in open or percutaneous spine procedures. It can also be used for measuring and selecting the fixation rod for the thoracic and lumbosacral spine.

In conclusion

Applications of augmented reality (AR) and virtual reality (VR) for medical use continue to grow rapidly. FDA has cleared 69 AR/VR based medical devices as of September 2024. Most of these applications are in the Radiology and Orthopedic space, dominated by the software for image processing and sterotaxic spinal procedures. These cutting edge technologies enable more precise location and measurement of anatomical structures and pre-operative planning for better patient outcomes.

References

1. FDA: Augmented Reality and Virtual Reality in Medical Devices
2. Immersive Touch, Inc.: Immersiveview(TM) 5 planning software
3. Medacta International: NextAR (TM) spine

Disclaimer

Examples of medical devices used in this article are intended for informational purposes only. I have no affiliation with any company cited above.

If you liked this article, you might also enjoy Tracking rapid growth of AI/ML medical devices in 5 charts