PALO ALTO, Calif., Jan. 29 /PRNewswire/ -- Nfocus Neuromedical Inc. today announced that the Company’s quality system has received certification to the rigorous medical device standards of ISO 13485:2003. The Company was audited and certified by the European Notified Body, TUV SUD Product Service of Munich, Germany. The certification of a Quality System clears the certified company to seek and complete further product-specific approvals in Europe and the US in preparation for product launch and marketing.
“I am proud of the Nfocus team of professionals whose efforts produced our exceptional Quality System,” said Martin S. Dieck, President and CEO of Nfocus. “Achieving the important milestone of ISO certification is a key step on our road toward product launches later this year.”
Nfocus will carry on its development programs within its quality system as it prepares to bring its current aneurysm and fistula treatment devices to market in Europe and the US. The company’s development programs are focused on providing faster, simpler and more permanent treatment of hemorrhagic stroke conditions through endovascular (less invasive) devices.
Hemorrhagic stroke caused by ruptured aneurysms is a critical and often life-threatening event most frequently brought on by a rupturing aneurysm or other vascular malformation. In tens of thousands of cases, open surgery may not be ideal or even possible, but the alternative, today’s endovascular devices, may not provide permanent treatment. It is these critical and underserved patients and their physicians, the neurointerventional surgeon, that Nfocus is committed to serve.
For more information about aneurysms and hemorrhagic stroke see: http://www.strokeassociation.org and http://www.asitn.org
About Nfocus Neuromedical, Inc.
Nfocus is a neurovascular development, manufacturing and marketing company focused on treating hemorrhagic stroke. Current and future product programs are aimed at rapid treatment of aneurysms and fistulas in the brain. Based in Palo Alto, California, Nfocus is privately held and venture capital backed. See http://www.nfocusneuro.com for further information. Nfocus products will be used by neurosurgeons and interventional neuroradiologists performing less-invasive surgery using endovascular catheters in procedures known as neurointerventional surgery.
CONTACT: Martin S. Dieck, President and CEO, +1-650-845-3040,
martin@nfocusneuro.com, or Thomas W. Ross, Executive VP, +1-650-845-3042,
tom@nfocusneuro.com, both of Nfocus Neuromedical Inc.
Web site: http://www.nfocusneuro.com/
http://www.strokeassociation.org/
http://www.asitn.org/
