Augmented Reality (AR) and Virtual Reality (VR) in Healthcare: Demonstrating Optical Compliance for the FDA

PISEO: testing, measurements and strategic support to ensure your AR/VR devices meet requirements and access the U.S. market.

Virtual and augmented reality glasses have experienced rapid growth in recent years.

Beyond their leisure uses, such as video games or social interactions, these technologies are now opening up revolutionary opportunities in the medical field. Imagine a surgeon training to perform a complex procedure in a virtual environment, or doctors operating remotely on a patient located on the other side of the world, these innovations are now becoming reality.

A challenge of safety and reliability

In the medical sector, an error can put lives at risk. The reliability of the technologies used is therefore an absolute priority.

For several years, PISEO has supported international clients in the qualification of their optical devices intended for the U.S. medical market, in compliance with the strict requirements of the Food and Drug Administration (FDA).

To obtain this approval, essential for any commercialization in the United States, AR/VR systems must meet precise optical performance criteria.

PISEO: recognized optical expertise

As the only independent optical laboratory in France and one of the few worldwide, PISEO offers a comprehensive range of tests designed to evaluate and certify the electro-optical performance of photonic components and systems.

This expertise has led the FDA to directly refer some of its clients to PISEO to conduct the tests required to obtain product approval.

Thanks to its know-how, PISEO has enabled 100% of its clients to obtain U.S. approval.

PISEO: A comprehensive approach to obtaining FDA approval

PISEO evaluates the optical performance of augmented and virtual reality glasses, as well as their integrated displays, which are essential for projecting information.

The objective is to perform several measurements such as:

  • display luminance
  • contrast and distortion of projected images
  • response under specific ambient light levels simulating operating room conditions
  • spatial persistence of displayed information

To conduct these tests, the company relies on state-of-the-art equipment, including luminance measurement cameras, colorimeters and controlled illumination systems that reproduce precise and repeatable lighting environments, particularly those found in operating rooms.

PISEO also offers more specific tests that directly integrate the client’s application.

AR/VR in healthcare
AR / VR médical

Innovation and forward-looking insights: smart glasses under PISEO’s lens

PISEO does not stop there. A comparative report on smart glasses performance has recently been published.

This new category of augmented reality glasses is designed like conventional eyewear but integrates advanced technological features.

The report includes detailed measurements of each electronic component integrated into these glasses, with the aim of optimizing key aspects such as reducing energy consumption, a major challenge for the connected technologies of tomorrow.

For more information about PISEO services and to discover how we can support the qualification of your optical devices, contact us.

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