Axilum TMS Robot
Regulations in the European Union : Axilum Robotics TMS-Robot is manufactured by Axilum Robotics. It is a device for medical or scientific investigation purposes, in order to automate the positioning of a Transcranial Magnetic Stimulation coil. Before any use, please read the user manual. Axilum Robotics TMS-Robot is not a CE marked medical device.
Regulations in the USA : In the USA, federal law regulates the sale of Medical Devices through the US Food and Drug Administration (FDA). This is done to ensure safety and effectiveness. Devices which are permitted to be marketed for their intended use must either have a 510(k) or PMA clearance. Axilum Robotics TMS-Robot is not FDA cleared. Please note that the use of Axilum Robotics TMS-Robot for the positionning of Transcranial Magnetic Stimulation (TMS, rTMS) coil is considered investigational in the USA. For further information please contact Axilum Robotics.
Regulations in other countries : For regulations of Axilum Robotics TMS-Robot outside the European Union or the USA, please contact Axilum Robotics.