HoloRay Announces U.S. FDA Class I Approval for HoloPod Device
HoloRay, a provider of web-based software and plug-and-play hardware for clinical education and guidance, has received FDA Class I registration for its HoloPod product as a Medical Device Data Systems device.
"Receiving FDA Class I registration for HoloPod, building on the existing registration of HoloXR, marks an important milestone for HoloRay and a strong validation of our approach to practical, interoperable clinical technology. Our goal has always been to make expert collaboration accessible in real clinical environments, without adding complexity. This approval supports our mission to help healthcare teams connect, train, and make decisions together, regardless of location."
Dr. Renzo Cecere, President, CEO, HoloRay
About HoloPod
HoloPod is a lightweight, IoT, plug-and-play device that captures live video/data from hospital machines and sends it to secure HoloXR telecollaboration sessions so experts can see what's happening as if they were physically present. The device is compatible with nearly all hospital imaging and diagnostic systems and supports diverse clinical use cases. HoloPod provides remote specialists with comprehensive insights into a patient's condition, enabling accurate collaboration with on-site staff.
About HoloXR
HoloXR is a next-generation telecollaboration platform designed to expand clinical and technical communications far beyond conventional consultations. With 3D and 2D annotations and accessibility via desktop, laptop, tablet, phone, or a compatible mixed reality headset, HoloXR lets healthcare professionals and medical device and implant manufacturers and distributors connect and collaborate from anywhere.
About HoloRay
HoloRay is a health technology company that democratizes access to healthcare and expert training by designing and building advanced software and hardware solutions. HoloRay emerged from research in surgical robotics and mixed reality at McGill University, where founders recognized that powerful clinical technologies were often fragmented, inaccessible, and difficult to integrate into real-world clinical environments. Today, HoloRay delivers a connected ecosystem for remote care, education, and simulation to remove barriers to healthcare and expert training. HoloRay is redefining healthcare through collaboration and equal access to expertise, from anywhere in the world.