FDA Clears Apollo TMS Therapy Devices for Adolescent Depression

Apollo transcranial magnetic stimulation (TMS) therapy devices by neurocare group have received FDA clearance for treating adolescents with major depressive disorder (MDD).

Major depression affects an estimated 5 million adolescents in the U.S. each year, yet treatment options remain limited. Currently, only two oral antidepressants are FDA-approved for use in this age group, and both carry a “black box” warning-the strongest warning the FDA issues for medications-due to an increased risk of suicidal thoughts and actions. These medications have an effectiveness rate of only about 35% in achieving remission, and many patients discontinue due to side effects or lack of clinical benefit.

TMS offers a safe, non-invasive, and drug-free alternative, with no black box warning and no medication-related side effects. Clinical studies show that approximately 60% of patients achieve remission with TMS, making it a promising new treatment option for adolescents who have not found success with other treatments.

During TMS Therapy, clinicians position a magnetic coil on the patient’s head to deliver targeted stimulation to specific brain regions involved in mood regulation. neurocare’s engineering team in Germany has developed advanced technology where the magnetic field is more efficient at providing the prescribed stimulation. This advancement improves the impact of treatment, giving patients the best possible chance to benefit from their psychiatrist’s prescribed therapy.

“Our mission has always been to expand access to safe and effective treatments for those who need them most,” said Stanford Miller, Managing Director of neurocare group’s North American operations. “This clearance allows providers to offer adolescents a proven therapy without the risks and limitations of medication, giving hope to families searching for better treatment options.”

Since 2021, neurocare has installed more than 300 Apollo systems in clinics and major institutions across the U.S., helping with the treatment of complex cases of Major Depressive Disorder (MDD) in adults, as well as Obsessive Compulsive Disorder (OCD). The Apollo TMS Therapy product line is FDA-cleared for the treatment of MDD in adult patients who have not had an adequate response to oral antidepressants. It is also FDA-cleared as an adjunctive treatment for OCD in adult patients who have not responded to traditional therapies. The same advanced technology is now FDA-cleared as an adjunctive treatment for adolescents with MDD. Most private and public insurers cover TMS Therapy for adults with MDD, and an increasing number are extending coverage to adolescents.