USA - FDA Clearances
United States federal law regulates the sale of Medical Devices. The US Food and Drug Administration (FDA) grants clearance to manufacturers to market devices for specific indications, after safety and efficacy have been demonstrated, by issuance of either a 510(k) or PMA clearance.
Apollo TMS: Indication for Use
The Apollo TMS Therapy System is FDA 510(k) cleared for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode (K180313).
