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| Land | Sverige |
|---|---|
| Lista | First North Stockholm |
| Sektor | Hälsovård |
| Industri | Medicinteknik |
BrainCool AB (publ) has received a CB-certificate from NEMKO for a new generation of RhinoChill® System. The development of RhinoChill has taken place within the framework of the EU project for cooling treatment of stroke patients treated by thrombectomy which started in autumn 2020.
The CB certificate is the summary certificate for several test reports and certificates regarding the safety of EMC (electromagnetic compatibility) and various safety tests. The basis available for a CE-marked product is usually not sufficient for access to markets outside the EU/EFTA. As a rule, additional tests and certification are required. National Certification Bodies (NCBs) and test laboratories in 39 countries, 20 of which are located outside the EU, participate in the CB system.
NEMKO is a well-established CB Test Laboratory in MedTech industry providing a high quality and recognized pathway to international compliance.
The new generation of the product is intended to be approved within the EU in the new regulatory framework MDR as well as in the US by the FDA during an ongoing De Novo 510 k process.
CEO Martin Waleij comments;
CB certification is a time and cost-effective way to reach several markets outside the EU and will facilitate the regulatory and market expansion of the product. The CB certificate is a cornerstone for being able to pursue the company's regulatory projects for the product in both the EU and the US and will now also be able to be used in the Cottis 2 study.
The RhinoChill is portable, battery-powered and intended for temperature reduction by cooling through the nasal cavity, which includes rapid initiation of therapeutic hypothermia for stroke or cardiac arrest in the field or hospital setting.