Midjourney Medical Avoids FDA Rules by Selling Ultrasound as "Wellness," Not Medicine

Midjourney Medical plans to sell its full-body ultrasound scanner through a San Francisco spa by end of 2027, calling it wellness rather than medical diagnosis. This sidesteps FDA approval required for clinical devices. The problem: if the scanner spots something abnormal—a tumor or fluid—the "wellness" label creates legal and regulatory risk the FDA will likely challenge.