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

My Subscriptions

Payment Confirmation

Transaction Failed

Your transaction failed, please try again or contact site support.

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.

spot_img

DON'T MISS

Mediclinic Appoints 2 New Independent Non-Executive Directors

Natalia Barsegiyan and Zarina Bassa will bring significant and diverse skills and experience, complementing those of existing Board members. I am confident they will both be great additions to our Board of Directors.”

Asensus Surgical Appoints Two New Board Members

Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company that is digitizing the interface between the surgeon and the patient to pioneer a new era of Performance-Guided Surgery™, today announced the expansion of its Board of Directors, appointing...

Our Sister Publication: Biotechnology News Magazine

Subscribe to Medical Device News Magazine here.