Neuronetics (Nasdaq:STIM) announced today that it received FDA 510(k) clearance for its D-Tect MT accessory for the NeuroStar platform.
Malvern, Pennsylvania-based Neuronetics designed its D-Tect accessory to simplify the motor threshold (MT) determination for physicians.
According to a news release, the now FDA-cleared technology gives clinicians a way to determine MT by visually reporting the magnitude of finger movements during MT mapping for the treatment of major depressive disorder (MDD).
D-Tect also allows the MT determination to be performed by just one person, Neuronetics said. The company will make D-Tect available through a limited commercial launch initially, with a national rollout slated for mid-September. Practices will be trained on the product at NeuroStar University, which recently opened in Charlotte, North Carolina.
“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,” said Cory Anderson, VP of R&D and clinical at Neuronetics. “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.”
D-Tect recognizes the movement in three areas of the hand without the requirement of cords or sensors attached to the patient. It gives the clinician data that includes a comparison of the response to the current pulse against the previous pulse and complements NeuroStar’s Fast MT and the MT Cap offerings.
Neuronetics estimates that the D-Tect accessory delivers an average time savings of 40% for physicians during their MT determination.
“It’s outstanding to see tangible results from NeuroStar’s ongoing commitment to invest in product innovations that deliver real value to practices like mine by streamlining the entire NeuroStar TMS treatment process,” said Dr. David Sikowitz of The TMS Center of New Jersey. “Having the latest technology to assist in determining a patient’s motor threshold will make my team more efficient while also allowing us to deliver the best patient care by personalizing each patient’s treatment while saving time.”