MedTech Dive March 27, 2024
Nick Paul Taylor

William Blair analysts called the clearance a positive surprise, explaining that the FDA has denied several therapies in the patient population.

Dive Brief:

  • Neuronetics received 510(k) clearance to use its transcranial magnetic stimulation (TMS) device to treat adolescents with major depressive disorder (MDD).
  • The Food and Drug Administration expanded the label to cover people aged 15 to 21 years after Neuronetics shared real-world data linking its device to clinically meaningful improvements in the severity of depression in 78% of patients, according to the company’s Monday announcement.
  • William Blair analysts called the clearance a positive surprise, explaining that the FDA has denied several therapies in the patient population. Neuronetics competes with Brainsway, Apollo TMS, Magstim, Magventure, CloudTMS and Nexstim for...

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Topics: FDA, Govt Agencies, Medical Devices
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