Nexstim received diagnostic approval also in the US

Translation: Original published in Finnish on 10/13/2025 at 7:40 am EEST.

Nexstim announced on Friday that it had received diagnostic approval for its NBS 6 system in the United States. The news follows the recent similar MDR certification in Europe, which we commented on here. With these new marketing authorizations, Nexstim can now sell the NBS 6 system with diagnostic modules, in addition to the previously approved therapy modules.

NBS 6 now has all regulatory approvals in key markets

The company already received approvals for the therapeutic use of the NBS 6 system in Europe and the United States in 2023. The company was already aiming for diagnostic marketing authorizations last year, but the regulatory processes have been somewhat delayed, which is typical for the industry. We have commented on the content and delays of the EU MDR at a general level in this article.

Regulatory approvals for diagnostic applications in the EU and the US have been one of Nexstim's key strategic objectives for this year. These approvals are thus in line with the company's own targets and our expectations.

Some customers can update existing equipment with new features

Nexstim's customers have been able to order the NBS 5 system with the option to upgrade it later to NBS 6. We estimate that there is a limited number of upgradable systems and that the financial significance of the upgrade for Nexstim is minor. Despite the upgrade possibility, some customers may have waited to purchase until NBS 6 diagnostic approval, which could lead to delayed demand materializing in the coming months. We have tried to take this into account in our forecasts, so the expected news does not affect our view of the stock at this stage.