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.