NuLoupes
Company: NuEyes AR Smartglasses
Product website: https://www.nueyes.com/nuloupes
Authors: Katie Carsky, MD, David Schwartzberg MD, FACS, FASCRS
NuEyes received FDA Class I 510(k) exemption for NuLoupes AR (Augmented Reality) Smartglasses in December 2023. Class I 510(k) exempt devices do not require premarket approval because they are considered low risk, but they are still subject to FDA (Food & Drug Administration) oversight and adherence to general FDA controls to ensure safety and efficacy.
NuLoupes is the first electronic 3-dimensional stereoscopic wearable surgical magnifier. In contrast to present-day analog loupes, NuLoupes allow for continuous high-resolution magnification from 1x to 13x to provide greater detail of the surgical field. They deliver enhanced depth perception surpassing that of the human eye. Two lenses are fixed at slightly different angles in order to create an augmented reality 3-dimensional visual effect. The device is lightweight and ergonomic to reduce back and neck strain with a 90-degree pivoting camera. It is equipped with dual headlamps and provides a 42-degree field of view. The hardware is voice controlled for ease of use while sterile. The device allows for image capture and video recording, and images and video can be downloaded to another device for use.
NuEyes aims to host a variety of apps on the NuLoupes device in the future. They intend to integrate dictation capabilities and operative reporting. Additionally, they plan to add surgical navigation and object recognition to the software to enhance intraoperative decision-making.
The device is one of several products created by the company. They have used adjacent technology to develop artificial intelligence glasses for visually impaired consumers such as those with macular degeneration. They have also created smart glass displays for entertainment systems.
NuLoupes are intended to enhance surgical and dental visualization. Current indications include use for stereoscopic electronic magnification to provide improved surgical visualization. The only contraindicated situation is that of uploading non-FDA approved software to the device for intraoperative usage.
The FDA Class I 510(k) exemption was announced by NuEyes in December 2023, and the NuLoupes product is slated for release in Q1 of 2025.
Image from nueyes.com/nuloupes