FDA 510(k) clearance for microINR
March 15, 2019 iLine Microsystems SL | Booth #2321
iLine Microsystems announces FDA 510(k) clearance for microINR System, a Point-of-Care device for oral anticoagulation monitoring
iLine Microsystems announces today that the US Food and Drug Administration (FDA) has granted 510(k) clearance for the microINR System.
iLine Microsystems and microINR are well consolidated with strong presence in more than 50 countries and a substantial number of approvals by multiple regulatory authorities.
Clinical studies performed in the USA have once again confirmed that microINR is a top-quality device with excellent correlation with the reference laboratory.
The microINR System is a hand-held device for monitoring anticoagulation therapy with vitamin K antagonist drugs such as warfarin. The system offers highly innovative advantages such as an automatic calibration and minute blood sample requirement that are key for end-user satisfaction and patient safety.
“Healthcare professionals in the US will now have access to this high-performance device and patients will strongly benefit from it. The clearance by FDA is a further recognition of the quality and performance characteristics of the microINR System and a means not only to enter an expansion phase for the company, but also to support the work of our customers across the five continents. The company continues its consolidation as a world reference in the field of hemostasis POCT” said Iñaki Sadaba, CEO of iLine Microsystems.
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