ClearLine MD said today that it won CE Mark approval for its ClearLine IV product line that prevents air from being introduced into intravenous lines.
During IV infusion, ClearLine’s device detects air in the IV line using ultrasound and then removes the air to allow the fluid to flow continuously. Air embolisms can cause long-term clinical complications such as extended hospital stays and medical liability costs. According to the Centers for Medicare & Medicaid Services, air embolism is the 2nd most serious, preventable adverse hospital event.
The Woburn, Mass.-based company will bring the ClearLine IV system into hospitals in Benelux, Scandinavia and Switzerland, expanding ClearLine’s distribution network into European markets.
“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,” president & CEO Ann Bilyew said in prepared remarks.