Medical technology company Neuronetics has secured 510(k) clearance for its D-Tect MT Accessory designed for NeuroStar Advanced Therapy for mental health.
The latest accessory for NeuroStar Advanced Therapy is intended to simplify the motor threshold determination for physicians.
The FDA-cleared device assists therapists in the treatment of the major depressive disorder (MDD) by reporting the size of finger movements during motor threshold (MT) mapping.
Neuronetics said D-Tect also allows the MT determination to be performed by only one person and can be integrated across all NeuroStar systems.
According to the firm, a restricted commercial launch will be used to introduce the D-Tect MT Accessory at first, with a nationwide rollout starting in mid-September.
Additionally, NeuroStar University, which recently opened in Charlotte, North Carolina, will train practitioners on the new product.
Neuronetics R&D and Clinical VP Cory Anderson said: “The FDA clearance for the D-Tect MT Accessory is the next chapter in our plan to simplify and accelerate the MT determination for NeuroStar providers.
“This product aids physicians as they determine the treatment location and treatment level for new patients, and we’re excited to announce that this patent-pending technology is compatible with all new and existing NeuroStar systems.”
The D-Tect MT Accessory does not need to have any cords or sensors attached to the patient to detect movement in three different locations of the hand.
Compared to the present visual method, this speeds the process and gives the doctor more information, such as a comparison of the response to the current and prior pulses.
The D-Tect MT Accessory completes NeuroStar’s Fast MT and MT Cap breakthroughs, completing the motor threshold determination process and providing doctors with an average time savings of 40%.
In July this year, the company received clearance from the US FDA for NeuroStar Advanced Therapy made for the treatment of anxious depression.
