NeuroLogica Receives CE Safety Mark Certification For The NL3000 CereTom(TM) CT

DANVERS, Mass.--(BUSINESS WIRE)--NeuroLogica Corporation today announced it has received the CE product safety certification mark from SEMKO AB, Sweden. This approval will allow entry of the CereTom(TM), the first portable and cordless CT scanner, into medical facilities throughout the European Union as well as other countries that accept the CE Mark. NeuroLogica will install the CereTom at its first European luminary site at the University Hospital, Linkoping, Sweden.

"This is a major accomplishment for our company, and it will allow us to further our mission, of bringing greater access globally to quality, mobile neuro-imaging," Eric Bailey, President and Co-founder of NeuroLogica Corporation, stated. "In addition to leading medical centers in the US using the CereTom, including The Massachusetts General Hospital and UCLA Medical Center, hospitals in Europe will now have access to the world's first portable and cordless CT scanner. CereTom will be installed in multiple luminary sites across Europe in the coming weeks."

For the CE Mark, the CereTom was evaluated against the applicable medical device safety standards: EN60601-1, EN60601-1-1, EN60601-1-2, EN60601-1-4, EN60601-2-32, EN60601-2-44, manufacturing, documentation and systems compliance reviews.

Vertec Scientific Ltd. will serve as both NeuroLogica's EU representative and their official distribution partner for the CereTom throughout the UK and Europe. NeuroLogica will next apply for the appropriate certification required for global distribution including Japan, China, Hong Kong, Korea and India.

About NeuroLogica:

Based in Danvers, Mass., NeuroLogica Corporation, a neuro-science based imaging company, develops, manufactures and markets advanced medical imaging equipment. The company's mission is to bring access to high quality neuro-imaging to all people regardless of where they live. Combining superior imaging quality and easy access enables physicians to make more informed treatment decisions that save and improve patient lives, specifically in neuro-related conditions.

Contact: Racepoint Group Tom Bain/Andrea Krull, 781-487-4600 neuro-logica@racepointgroup.com

Source: NeuroLogica Corporation

>>> Discuss This Story

MORE ON THIS TOPIC