Healium Announces FDA Registration of Healium Clinical as a Class II 510(k)-Exempt Biofeedback Medical Device

FDA Registration Accelerates Healium Clinical's Expansion into Healthcare Settings Nationwide

COLUMBIA, Mo., May 20, 2026 /PRNewswire/ -- For decades, biofeedback has relied on graphs and monitors. With this new FDA registration, a new generation of immersive technologies is transforming physiological data into cinematic, interactive experiences that patients can see, feel, and influence in real time.

For clinicians navigating the growing demand for non-pharmacological tools, finding an engaging biofeedback and neurofeedback solution with the regulatory standing to support clinical workflows has been a persistent gap. Today, Healium announces a milestone designed to close it.

Healium has been registered with the U.S. Food and Drug Administration 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 platform is evidence-based in nine peer-reviewed journals to quickly reduce anxiety or improve mood in as little as 4 minutes. A randomized controlled trial conducted at Mayo Clinic observed significant reductions in preoperative anxiety among cardiac surgery patients.

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."

National Momentum Across Veteran and Clinical Care

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.

A New Category of Immersive Clinical Biofeedback

Healium Clinical is intended for use under the direction and supervision of a qualified healthcare provider and utilizes a prescription-use workflow. In this context, "prescription" refers to a lawful provider order and does not require pharmacy fulfillment.

The registration formally positions Healium Clinical within the FDA's established biofeedback device framework while supporting healthcare organizations seeking engaging, documented, and privacy-conscious digital health solutions.

Two Distinct Healium Platforms

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.

Organizations and healthcare providers interested in learning more about Healium Clinical can contact [email protected]

About Healium: the Company

Healium is a non-pharmacological digital health company with technology that delivers immersive experiences for relaxation training. Evidence-based in multiple peer-reviewed journals and trusted by behavioral health clinics, pain clinics, federal agencies, and VA clinics nationwide, Healium is built on the belief that the mind is a powerful tool — and that people can learn to self-regulate it.

Media Contact: Lydia Melton [email protected] (573) 214-0504

SOURCE Healium