The Samsung Electronics subsidiary received approval for its OmniTom Elite, BodyTom Elite and CereTom Elite mobile CT systems.
“The achievement of this certification sheds light on our continued dedication to bringing innovative solutions to hospitals and clinics globally,” said Jason Koshnitsky, senior director of global sales and marketing, NeuroLogica. “It will allow a greater number of healthcare providers to have access to cutting-edge diagnostic imaging to deliver high-end patient care.”
Danvers, Massachusetts-based NeuroLogica’s CT systems comply with the new EU MDR guidelines. Those guidelines emphasize technical documentation, clinical data and post-market surveillance.
“NeuroLogica already complies with the United States Food and Drug Administration quality system regulations and is certified to ISO 13485 standard,” said Dr. Ninad Gujar, VP of regulatory affairs, quality assurance and corporate compliance. “Our products and processes comply with global regulatory requirements allowing design, manufacturing, installation, service and engineering of imaging systems for medical applications. Compliance with EU MDR is an important regulatory milestone that exhibits NeuroLogica’s efforts towards demonstrating conformance to EU regulatory requirements, making mobile CT systems available in the European Economic Area and remaining committed to product quality and safety.”
NeuroLogica said it has existing partners in Europe working as economic operators. In addition, it established a network of distributors to support customers.
The company plans to continue manufacturing its mobile CT product line in Danvers, exporting the systems to Europe.