Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0)

The Horizon 3.0 TMS Therapy System is a computerized medical device that delivers transcranial magnetic stimulation (TMS) to treat Major Depressive Disorder in adults who have failed antidepressant medication and as an adjunct for Obsessive-Compulsive Disorder in adults and Major Depressive Disorder in adolescents (ages 15–21). It uses brief, pulsed magnetic fields to induce electrical currents in the prefrontal cortex and is operated by prescription under physician supervision in clinical or office settings.

The Horizon 3.0 system is offered in three configurations (Horizon 3.0, Horizon 3.0 Inspire, and Horizon 3.0 with StimGuide Pro), all sharing identical core components, operating principles, and treatment protocols. Key differences from the predicate NeuroStar include coil construction (Ez Cool Coil and Air Film Coil versus Neuronetics Coil), but magnetic field characteristics, output waveforms, spatial distribution, and field strength at clinically relevant depths (2–3 cm) are substantially equivalent. All configurations deliver the same treatment protocols (rTMS and iTBS) at 120% of motor threshold to the left dorsolateral prefrontal cortex.

IEC 60601-1 (electrical and mechanical safety), IEC 60601-1-2 (electromagnetic compatibility), IEC 60601-1-6 and IEC 60601-1-8 (general requirements and alarms), IEC 62304 (software lifecycle), IEC 62366-1 (usability/human factors), ISO 10993-1 (biocompatibility), ISO 14971 (risk management), AAMI/ANSI HE75 (human factors), AAMI TIR57 and TIR97 (software and security), and FDA guidance for rTMS systems.

The device demonstrates substantial equivalence through identical principles of operation, intended use, and treatment protocols compared to the NeuroStar predicate. Although the coils differ in construction, magnetic and electrical field testing in a phantom head model showed equivalent field characteristics, output waveforms, and spatial distribution at the clinically relevant stimulation depth of 2–3 cm. All three configurations passed the same battery of safety and performance tests (EMC, electrical, thermal, software, human factors) with results equivalent to the predicate. The addition of the adolescent indication (ages 15–21) does not raise new safety or effectiveness questions because the device operates identically and performance data confirms equivalent magnetic field delivery across all age groups.