CloudTMS Edge

The CloudTMS Edge is a repetitive transcranial magnetic stimulation (rTMS) system that uses pulsed magnetic fields to induce electrical currents in cortical neurons. It is indicated for treatment of Major Depressive Disorder in adult patients who have failed prior antidepressant medications. The device can be used in patient care institutions, diagnostics centers, and neurosurgical hospitals.

The CloudTMS Edge shares the same figure-of-eight coil design and principle of operation as its predicates (MagVita TMS Therapy K173620 and CloudTMS K173441). It provides three treatment protocols (iTBS, 19-minute, and 37-minute sessions) at 120% motor threshold, combining capabilities of both predicates. Coil parameters vary slightly in dimensions and windings across models, with liquid cooling and forced-air cooling options. Pulse widths range from 265–305 microseconds across coil variants, and amplitude ranges from 0–3.1 SMT units depending on coil model.

IEC 60601-1 and IEC 60601-1-2 (electrical safety and electromagnetic compatibility); ISO 13485:2012 (quality management); ISO 10993-1:2009 (biocompatibility); ISO 14971:2007 (risk management). Performance testing included electric field strength decay, magnetic field waveform, spatial distribution, and gradient measurements per the FDA Guidance for rTMS Systems.

The subject device delivers identical indications, treatment targets, treatment protocols, and standard treatment parameters (120% MT, 50 Hz / 10 Hz frequency, 2–4 second train duration, 8–26 second inter-train intervals, 20–75 trains per session, 600–3000 pulses per session) as the predicates. Although coil dimensions, windings, and pulse widths show minor variations typical of different TMS manufacturers, bench-top performance testing demonstrates equivalent electrical and magnetic field characteristics. Since patients are always treated at 120% motor threshold (which compensates for pulse width differences through intensity adjustment), and variation in individual pulses within iTBS bursts is less than 1%, the device introduces no new safety considerations and performs substantially equivalently to the predicates.