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August 30, 2022

Neuronetics secures FDA 510(k) clearance for D-Tect MT Accessory

The D-Tect MT accessory recognises movement in three hand areas and does not require cords or sensors.

Neuronetics has received 510(k) clearance from the US Food and Drug Administration (FDA) for its D-Tect MT Accessory.

The technology simplifies motor threshold (MT) determination for physicians by visually reporting the magnitude of finger movements during MT mapping for the treatment of major depressive disorder (MDD).

Additionally, it enables the determination of MT to be performed by a single person.

Designed to be used as an accessory to the NeuroStar System, the new MT detection device recognises movement in three hand areas without requiring cords or sensors to be attached to the patient.

The D-Tect MT Accessory complements NeuroStar’s Fast MT and MT Cap offerings and provides more data to clinicians, including a comparison of the response to the existing pulse against the response to the previous pulse.

Neuronetics expects the new technology to save up to 40% of the average time spent on MT determination by clinicians.

Neuronetics R&D and Clinical vice-president 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.”

Initially, the company will make D-Tect available through a limited commercial launch. This would be followed by a national rollout commencing in mid-September.

Practices will get training on the D-Tect MT Accessory at NeuroStar University, which was recently opened in Charlotte, North Carolina, US.

Neuronetics’ MT Cap technology received 510(k) clearance from the FDA last December.

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