Axilum Robotics Announces U.S. FDA 510(k) Clearance for TMS-Cobot

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Axilum Robotics, specializing in the development of medical robots, announces that, 2 weeks after the CE mark, the Company has received 510(k) clearance from the U.S. Food and Drug Administration to market the TMS-Cobot TS MV, indicated for the spatial positioning and orientation of the treatment coil of the MagVenture TMS Therapy system.

After having successfully developed and launched outside of the United States (OUS) the TMS-Robot, the first robot designed to assist health care professionals in delivering Transcranial Magnetic Stimulation (TMS), based on an invention of ICube laboratory in Strasbourg, Axilum Robotics has reinforced its expertise in medical robotics with the development of a new platform based on collaborative robot technology.

TMS-Cobot, the first medical device built on this platform, allows the company to offer an affordable and versatile system, thanks particularly to a proprietary optical tracking system, which allows the control in real time of the position, orientation and contact of the stimulation device, with patient head motion compensation.

The compatible MagVenture TMS Therapy System is indicated in the U.S. 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. It was FDA cleared for this use on July 31, 2015.

Axilum Robotics’ TMS-Cobot TS MV will be distributed in the U.S. by MagVenture Inc. who is also the distributor of the MagVenture TMS Therapy System.

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