The US Food and Drug Administration (FDA) has granted 510(k) approval to Neuronetics for its MT Cap technology for Neurostar Advanced Therapy for Mental Health.
Neurostar Advanced Therapy for Mental Health is a non-invasive, non-drug, transcranial magnetic stimulation therapy intended for treating people suffering with major depressive disorder.
NeuroStar targets the depression source and helps to activate the natural functioning of the neurotransmitters in the brain using a non-invasive magnetic field.
Besides providing the starting location of a target, the MT Cap technology offers ‘step-by-step map’ to guide the identification process to motor threshold (MT) of a patient and cuts down several steps during the initial evaluation for NeuroStar.
Leveraging NeuroStar’s floating coil locking system, the MT Cap technology is claimed to make mapping and determining motor thresholds seamless.
Neuronetics clinical affairs and medical operations vice president Cory Anderson said: “We’re delighted to bring to market this latest in a series of technologies designed to make the motor threshold determination process simpler and more efficient for clinicians.
“We appreciate the ongoing collaboration with FDA that enabled a quick and efficient review process.”
The process of determining and locating MT in a patient takes up to 30 minutes and is a critical aspect of the treatment process.
Neuronetics noted that the combination of MT Cap technology with the Fast MT, which was recently launched, lead to an average time savings of about 40% during the MT determination process.
The company expects to begin a limited introduction of the technology in the weeks to come, with the country-wide rollout to begin in the first quarter of next year.
Last year, FDA granted breakthrough device designation for Neuronetics’s NeuroStar Advanced Therapy System to treat bipolar depression.