FDA 483 - Exthera Medical Corporation - June 04, 2025

Exthera Medical Corporation, a sponsor of investigational devices in Martinez, CA, was cited for three observations during an FDA inspection. The firm was found to have misrepresented an investigational device as safe and effective in promotional materials, distributed investigational devices for compassionate use without required FDA approval, and failed to ensure proper monitoring of informed consent for enrolled subjects in its studies.