Samsung Electronics subsidiary NeuroLogica has secured the European Union (EU) CE mark approval for its new Elite mobile computed tomography (CT) systems.
Via compliance with the new EU Medical Device Regulation (MDR 2017/745), the approval has been granted for the OmniTom Elite, BodyTom Elite, and CereTom Elite mobile CT systems.
The latest EU MDR replaced the earlier EU MDD to focus more on technical documentation, clinical data, and post-market surveillance.
NeuroLogica regulatory affairs, quality assurance, and corporate compliance vice-president Dr Ninad Gujar said: “NeuroLogica already complies with the United States Food and Drug Administration quality system regulations and is certified to ISO 13485 standard.
“Our products and processes comply with global regulatory requirements, allowing design, manufacturing, installation, service, and engineering of imaging systems for medical applications.”
NeuroLogica will continue to manufacture its CT product portfolio at its Danvers facility in Massachusetts, US.
These products will be exported to customers in the EU region.
NeuroLogica global sales and marketing senior director Jason Koshnitsky said: “The achievement of this certification sheds light on our continued dedication to bringing innovative solutions to hospitals and clinics globally.
“It will allow a greater number of healthcare providers to have access to cutting-edge diagnostic imaging to deliver high-end patient care.”
NeuroLogica is engaged in the development, manufacturing, and marketing of advanced imaging technologies.
The company, which has existing partners in Europe, provides its advanced technology to more than 50 countries across the world. It is also said to be the global corporate headquarters and manufacturer of mobile CT devices.