Ultimate rTMS

The Ultimate rTMS is a computerized repetitive transcranial magnetic stimulation system that produces non-invasive, pulsed magnetic fields to induce neural activity in the prefrontal cortex for treatment of Major Depressive Disorder in adults who have failed prior antidepressant medications. It can be used in clinical settings, diagnostic centers, and research institutions.

The Ultimate rTMS uses figure-of-eight coils (BY90A, BF90A, BY90B) with either liquid or forced-air cooling, delivers biphasic sinusoidal waveforms at 120% motor threshold with repetition rates of 10–50 Hz, and offers three treatment protocols (iTBS, 19-min, 37-min) targeting the left dorsolateral prefrontal cortex. It achieves identical or equivalent performance to predicates in magnetic field strength, pulse width (320 ±10%), pulse amplitude, coil temperature shutdown (40°C), and intensity stability among bursts (<1% variation).

The device complies with IEC 60601-1 and IEC 60601-1-2 (electrical safety), ISO 13485:2016 (quality management), and ISO 14971 (risk management). Electric and magnetic field characteristics, output waveform, magnetic field linearity, spatial distribution, and field gradient (dB/dt) were tested per FDA guidance for rTMS systems.

The Ultimate rTMS is substantially equivalent because it delivers identical treatment parameters (120% motor threshold, 5 sessions/week for 6 weeks, left DLPFC target, same session durations) to the predicate MagVita systems via the same figure-of-eight coil design and mechanism of action. Minor differences in coil dimensions, pulse width (320 vs 290 μs), and intensity settings are typical manufacturing variations among cleared rTMS devices and do not affect clinical outcome, as each device adjusts intensity individually to 120% of the patient's motor threshold. Performance testing confirms equivalent or superior magnetic field characteristics, output stability, and safety features, with no new safety concerns identified.