ClearLine MD Receives CE Certification for the ClearLine IV System
The first and only CE certified and FDA cleared device that automatically and continuously removes air from IV lines
WOBURN, Mass., Dec. 15, 2016 /PRNewswire/ -- ClearLine MD LLC, a medical device company focused on the development and commercialization of medical devices that protect patients against the dangerous intrusion of air in intravenous lines, today announced it has received CE certification for the company's ClearLine IV product line.
"The CE Mark approval is a significant milestone for ClearLine MD and enables us to provide an improved standard of care to hospitals in the European Union. We are finalizing our initial product launch in the EU for the beginning of 2017," said Ann Bilyew, President and CEO of ClearLine MD.
CE Mark approval expands the company's distribution network in European markets. Over the coming months, ClearLine MD will launch the ClearLine IV System at hospitals in Benelux, Scandinavia and Switzerland.
ClearLine IV prevents the introduction of air into the vascular system during IV infusion by detecting air in the IV line using ultrasound technology. The device then removes the air, enabling the continuous flow of fluid. ClearLine IV protects patients against the dangerous intrusion of air through IV lines and long-term clinical complications including extended hospital stays and medical liability costs associated with air embolisms.
About Air Embolism
An air embolism occurs when one or more air masses enter the circulatory system, causing blockage. Air often enters the circulatory system during medical procedures including through IV fluid lines. Air emboli may travel to the heart and brain, leading to shock and death. Per the Centers for Medicare & Medicaid Services, air embolism is the second most serious, preventable
adverse hospital event and is a non-reimbursable, hospital-acquired condition.
About ClearLine MD:
ClearLine MD is founded and funded by forward-thinking device engineers based on first-hand knowledge of an avoidable adverse event, air embolism. The Company is delivering a new standard of care for eliminating air from IV lines and avoiding the clinical complications associated with air embolisms.
For more information, visit: www.ClearLineMD.com.
SOURCE ClearLine MD
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