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The FDA flagged the facility for environmental monitoring and a facility investigation, as well as a deviation and calibration out of tolerance discrepancy. Read More
The device works with the MagVenture, which has been OK’d by the FDA for the treatment of major depressive disorder in patients who have not seen satisfactory improvement from antidepressant meds. Read More
The agency would allow healthcare providers to produce lower-risk personalized devices for patients without the need for manufacturing certification. Read More