NeuroLogica Receives CE Safety Mark Certification for the NL3000 CereTom(TM) CT
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.