Midjourney Medical Sidesteps FDA Clearance by Launching in a Spa, Not a Hospital

Midjourney Medical plans to debut its full-body ultrasound scanner through a San Francisco wellness spa by end of 2027, not hospitals. By framing the device as wellness rather than diagnostic, the company avoids FDA 510(k) clearance required for clinical claims. But if the scanner detects an abnormality—a mass or fluid collection—positioning it as wellness creates a liability and communication problem regulators may scrutinize.