Healium said it has been registered with the FDA as a Class II 510(k)-exempt biofeedback medical device under the product name Healium Clinical — a prescription-use, virtual reality software-enabled biofeedback, neurofeedback and relaxation training application intended for use under the supervision of a qualified healthcare professional.
Powered by virtual reality, mixed reality, and real-time biometric feedback, Healium Clinical transforms physiological signals such as heart rate and EEG brainwave activity into immersive visual experiences that respond dynamically as users learn relaxation and self-regulation techniques. By combining immersive media with biofeedback and neurofeedback, the platform is designed to help users actively participate in relaxation training rather than passively consume content.
The FDA registration places Healium Clinical within an established FDA-recognized category of regulated biofeedback devices, a significant step for healthcare organizations evaluating immersive digital health technologies for clinical deployment, reimbursement pathways, and broader integration into HIPAA-compliant clinical environments.
"Providers increasingly want technologies that do more than inform; they want tools that can help patients visualize, train, and influence their physiological state in real time," said Sarah Hill, CEO of Healium. "FDA registration of Healium Clinical strengthens the foundation for integrating immersive biofeedback, neurofeedback, and relaxation training into next-generation clinical care workflows."
Healium's immersive biofeedback kits combine virtual or mixed-reality experiences with wearable biometric sensors for EEG brainwave and heart-rate monitoring.
The platform is used in VA hospitals nationwide and powers the VA's largest deployment of in-home VR kits for Veterans. Healium is available to Veterans through their VA provider and more than 6,000 Veterans of Foreign Wars (VFW) posts across the country.
The registration also formalizes two distinct Healium platforms designed for different use cases. Healium Wellness is Healium's established flagship platform and the foundation for Healium Clinical, a new prescription-use platform created to support growing demand from healthcare providers.
Healium Wellness
A privacy-first wellness platform designed for schools, corporations, and non-clinical wellness environments, where a privacy wall helps protect individual user data from organizational administrators.
Healium Clinical
A prescription-use clinical platform designed for healthcare settings where qualified providers may access patient information to support onboarding, monitoring, documentation, and care-related workflows.
This Class II 510 (k)- exempt registration does not constitute FDA premarket review, approval, or clearance.
