NeuroLogica wins CE mark for mobile CT systems - Mass Device

[Image from NeuroLogica]

NeuroLogica announced contiguous that its Elite mobile computed tomography (CT) systems received CE people support successful Europe.

The Samsung Electronics subsidiary received support for its OmniTom Elite, BodyTom Elite and CereTom Elite mobile CT systems.

“The accomplishment of this certification sheds airy connected our continued dedication to bringing innovative solutions to hospitals and clinics globally,” said Jason Koshnitsky, elder director, planetary income and marketing, NeuroLogica. “It volition let a greater fig of healthcare providers to person entree to cutting-edge diagnostic imaging to present high-end diligent care.”

Danvers, Massachusetts-based NeuroLogica’s CT systems comply with the caller EU MDR guidelines. Those guidelines stress method documentation, objective information and post-market surveillance.

“NeuroLogica already complies with the United States Food and Drug Administration prime strategy regulations and is certified to ISO 13485 standard,” said Dr. Ninad Gujar, VP of regulatory affairs, prime assurance and firm compliance. “Our products and processes comply with planetary regulatory requirements allowing design, manufacturing, installation, work and engineering of imaging systems for aesculapian 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 disposable successful the European Economic Area and remaining committed to merchandise prime and safety.”

NeuroLogica said it has existing partners successful Europe moving arsenic economical operators. It besides established a web of distributors to enactment customers.

The institution plans to proceed manufacturing its mobile CT merchandise enactment successful Danvers. It past intends to export the U.S.-manufactured systems to Europe.