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FDA Approved: New Victories

24.09.2025
TMS

We have once again confirmed our expertise, the high quality of our products, and their compliance with international standards: the Neuro-MSX (CloudTMS Edge) magnetic stimulator is now officially FDA-approved for treating depression using intermittent theta-burst stimulation (iTBS)!

For this application, a wide range of coils (FEC-04-100-AC, FEC-03-100-C, AFEC-03-100-C, FEC-02-100-C, AFEC-02-100-C) has also been approved. It is important for therapy personalization and gives specialists the ability to select the optimal system configuration.

This system had previously received 510(k) clearance from the FDA for treating OCD. However, this new task presented a significant challenge for us: this is the first system in our product line to receive FDA clearance specifically for iTBS therapy! We succeeded!

This achievement strengthens Neuro-MSX's position on the global market and opens up new opportunities for doctors and patients.

FDA Approved: New Victories