Strasbourg, France-based Axilum Robotics said today that it has received 510(k) clearance from FDA for its TMS-Cobot TS MV, indicated for the spatial positioning and orientation of the treatment coil of the MagVenture TMS Therapy system.
Transcranial magnetic stimulation (TMS) is a non-invasive neurostimulation technique. Its approved and potential applications range from neuroscience research to the treatment of drug-resistant neurological or psychiatric diseases.
The procedure is usually implemented manually or with a fixed stand supporting the coil. When the coil is held manually or attached to a passive holder, the patient is required to stay perfectly still. The TMS-Cobot has a proprietary optical tracking system designed to allow healthcare professionals administering TMS real-time control of the position, orientation, and contact of the stimulation device while compensating for patient head motion.
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. FDA cleared it for this use in 2015.
MagVenture will distribute TMS-Cobot TS MV in the U.S. The Axilum robot received the CE Mark two weeks ago.
“TMS-Cobot will allow us to better address the needs of the TMS therapeutic market by providing an affordable solution to allow precise TMS delivery while relieving the operator from a demanding and time-consuming task and reducing the movement constraints on the patient,” said Axilum Robotics CEO Michel Berg in a prepared statement. “We are convinced that this robotized system represents a major step forward for the implementation of TMS.”