Beskrivning
| Land | Finland |
|---|---|
| Lista | First North Finland |
| Sektor | Hälsovård |
| Industri | Medicinteknik |
Company announcement, Helsinki, 9 October 2025 at 11:25 AM (EEST)
Nexstim’s NBS 6 diagnostics system receives MDR certification in the EU
Nexstim Plc (NXTMH:HEX) ("Nexstim" or "Company") has received certification for its NBS 6 diagnostics product under MDR (Regulation (EU) 2017/745) in the European Union.
With the certification received, Nexstim is allowed to start marketing and selling the NBS 6 system for pre-procedural mapping of the speech and motor cortices of the brain within the European Union.
In 2023, Nexstim announced the release of the NBS 6 for the treatment of major depression and chronic neuropathic pain within the European Union, and for the treatment of Major Depressive Disorder (MDD) in the United States. Due to the modularity of the system, customers will now be able to order the NBS 6 with a combination of therapy and diagnostic modules.
The NBS 6 enables Nexstim’s unique, clinically established navigated TMS technology to be used more easily than ever before. Part of this new product generation is an easy-to-use, embedded software and a modular product design that allows for system capabilities to expand over time and be highly customized based on a customer’s research or treatment interests.
More information on the NBS 6 system is available on Nexstim’s website: www.nexstim.com/healthcare-professionals/nbs-6.
Mikko Karvinen, CEO of Nexstim, comments: “Launching the NBS 6 diagnostics system is one of our key strategic objectives for 2025, and I am proud of the Nexstim team to have partly reach this goal with the certification in the European Union.
With both the diagnostic and therapy applications launched, we can now offer the NBS 6 combination system option to new and existing customers that in our experience greatly appreciate the opportunities for multi-departmental use that our products offer.
We are excited to take the message of our new product release to healthcare professionals.”
Further information is available on the website www.nexstim.com, or by contacting:
Mikko Karvinen, CEO
+358 50 326 4101
About Nexstim Plc
Nexstim is a Finnish, globally operating growth-oriented medical technology company. Our mission is to enable personalized and effective diagnostics and therapies for challenging brain diseases and disorders.
Nexstim has developed a world-leading non-invasive brain stimulation technology for navigated transcranial magnetic stimulation (nTMS) with highly sophisticated 3D navigation providing accurate and personalized targeting of the TMS to the specific area of the brain.
Nexstim’s Diagnostics Business focuses on commercialization of the NBS System 5 and NBS 6. The NBS System 5 is the only FDA-cleared and CE-marked navigated TMS system for pre-surgical mapping of the speech and motor cortices of the brain. The NBS System 6 is CE-marked for pre-surgical mapping of the speech and motor cortices of the brain.
Nexstim’s Therapy Business markets and sells the NBS System 6 which is FDA-cleared for marketing and commercial distribution for the treatment of major depressive disorder (MDD) in the United States. In Europe, the NBS 6 system is CE-marked for the treatment of major depression and chronic neuropathic pain.
Nexstim shares are listed on Nasdaq First North Growth Market Finland.
For more information, please visit www.nexstim.com