{"id":49550,"date":"2022-10-12T17:01:47","date_gmt":"2022-10-12T15:01:47","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/neurologica-receives-ce-marking-for-all-elite-mobile-computed-tomography-systems\/"},"modified":"2022-10-12T17:01:47","modified_gmt":"2022-10-12T15:01:47","slug":"neurologica-receives-ce-marking-for-all-elite-mobile-computed-tomography-systems","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/neurologica-receives-ce-marking-for-all-elite-mobile-computed-tomography-systems\/","title":{"rendered":"NeuroLogica Receives CE Marking for all Elite Mobile Computed Tomography Systems"},"content":{"rendered":"
\n

\nThe company\u2019s portfolio of mobile CT scanners to continue delivering high-quality CT imaging at the point-of-care within the European Union.<\/i><\/b>\n<\/p>\n

DANVERS, Mass.–(BUSINESS WIRE)–NeuroLogica Corp., a subsidiary of Samsung Electronics Co. Ltd., announced today that its state-of-the-art Elite Mobile Computed Tomography (CT) systems have received the European Union (EU) CE marking via compliance with the new EU Medical Device Regulation (MDR 2017\/745). The assessment and certification completed by the EU\u2019s Notified Body includes the approval of the OmniTom Elite, BodyTom Elite and CereTom Elite mobile CT systems.\n<\/p>\n

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\n\u201cThe achievement of this certification sheds light on our continued dedication to bringing innovative solutions to hospitals and clinics globally,\u201d said Jason Koshnitsky, Sr. Director Global Sales and Marketing, NeuroLogica. \u201cIt will allow a greater number of healthcare providers to have access to cutting-edge diagnostic imaging to deliver high-end patient care.\u201d\n<\/p>\n

\nThe EU MDR (EU Medical Device Regulation 2017\/745) replaced the previous EU MDD (Medical Device Directive 93\/42\/EEC). The updated regulations place a strong emphasis on technical documentation, clinical data and post-market surveillance. \u201cNeuroLogica 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,\u201d said Dr. Ninad Gujar, Vice President of Regulatory Affairs, Quality Assurance and Corporate Compliance. \u201cCompliance with EU MDR is an important regulatory milestone that exhibits NeuroLogica\u2019s 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.\u201d\n<\/p>\n

\nCurrently providing advanced technology to more than 50 countries globally, NeuroLogica has existing partners in Europe working as Economic Operators and an established network of distributors to continue to support customers. The company\u2019s mobile CT product line will continue to be manufactured in Danvers, Massachusetts in the United States, and will be exported to customers in the EU.\n<\/p>\n

\nAbout NeuroLogica<\/span><\/b>\n<\/p>\n

\nNeuroLogica Corp., the healthcare subsidiary of Samsung Electronics Co., Ltd., develops, manufactures, and markets innovative imaging technologies and is committed to delivering fast, easy and accurate diagnostic solutions to healthcare providers. NeuroLogica is the global corporate headquarters and manufacturer of mobile computed tomography devices. NeuroLogica\u2019s growing portfolio of advanced medical technologies are used worldwide in leading healthcare institutions helping providers enhance patient care, improve patient satisfaction, and increase workflow efficiency. For more information, please visit: http:\/\/www.neurologica.com<\/b><\/a> <\/span>\n<\/p>\n

\nAbout Samsung Electronics Co., Ltd.<\/span><\/b>\n<\/p>\n

\nSamsung inspires the world and shapes the future with transformative ideas and technologies. The company is redefining the worlds of TVs, smartphones, wearable devices, tablets, digital appliances, network systems and memory, system LSI, foundry and LED solutions. For the latest news, please visit the Samsung Newsroom at http:\/\/news.samsung.com<\/a><\/b>\n<\/p>\n

Contacts<\/b> <\/p>\n

\nMedia Inquiries
\n
<\/span><\/b>Jason Koshnitsky
\n
NeuroLogica Corp.
\n
508.904.3819
<\/span>jkoshnitsky@neurologica.com<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

The company\u2019s portfolio of mobile CT scanners to continue delivering high-quality CT imaging at the point-of-care within the European Union. DANVERS, Mass.–(BUSINESS WIRE)–NeuroLogica Corp., a subsidiary of Samsung Electronics Co. Ltd., announced today that its state-of-the-art Elite Mobile Computed Tomography (CT) systems have received the European Union (EU) CE marking via compliance with the new … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-49550","6":"format-standard","7":"category-industry"},"yoast_head":"\nNeuroLogica Receives CE Marking for all Elite Mobile Computed Tomography Systems - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/neurologica-receives-ce-marking-for-all-elite-mobile-computed-tomography-systems\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"NeuroLogica Receives CE Marking for all Elite Mobile Computed Tomography Systems - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"The company\u2019s portfolio of mobile CT scanners to continue delivering high-quality CT imaging at the point-of-care within the European Union. DANVERS, Mass.–(BUSINESS WIRE)–NeuroLogica Corp., a subsidiary of Samsung Electronics Co. Ltd., announced today that its state-of-the-art Elite Mobile Computed Tomography (CT) systems have received the European Union (EU) CE marking via compliance with the new ... 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