NBS 6 diagnostic system received MDR certification in the EU as expected

Translation: Original published in Finnish on 10/10/2025 at 7:00 am EET.

Nexstim announced on Thursday that it had received MDR certification for its NBS 6 diagnostic product in accordance with the EU Medical Device Regulation. The certification was expected and one of the company's key strategic objectives for 2025. The approval enables the sale of NBS 6 in Europe with both therapeutic and diagnostic features. The news, which is in line with the company's targets, does not cause changes to our forecasts at this stage.

With the approval, the NBS 6 system is available in Europe with all its features

With the certification, Nexstim can begin marketing and selling the NBS 6 system for pre-surgical mapping of the motor cortex and speech areas of the brain in the European Union. The company already received approvals for therapeutic use of the 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. The approval is thus in line with the company's own targets and our expectations. In the US, a similar process is still ongoing. As a basic assumption, we expect approval there as well in the near future, although there is no external visibility into the timing.

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.