Le Lézard
Classified in: Health
Subject: FDA

Coag-Sense® Second-Generation PT/INR Monitoring System Receives FDA Clearance


FREMONT, Calif., April 2, 2019 /PRNewswire/ -- CoaguSense, Inc., a subsidiary of i-SENS (KOSDAQ:099190), announced today that the U.S. Food and Drug Administration (FDA) has cleared its second-generation prothrombin time/international normalized ratio (PT/INR) monitoring system. The Coag-Sense® PT2 meter, designed for monitoring patients on Coumadin® (warfarin), delivers the same proven direct clot-detection technology in a design that can now be carried in a lab coat pocket and connected wirelessly to any clinical network or a patient's Bluetooth® home monitoring application.

CoaguSense Logo

"We are committed to not only providing a very safe and accurate device to monitor blood coagulation levels, but also one that is simple to use and offers a variety of seamless ways to export the test results into virtually any data management system," said Douglas Patterson, President and CEO of CoaguSense. "The Coag-Sense PT2 meter is the result of the continuous innovation of a test system based on the same mechanical principle as the World Health Organization's gold standard tilt-tube method and the research grade fibrometer."

The Coag-Sense PT2 meter received 510(k) clearance for the FDA for both professional use in a CLIA-waived setting and patient self-testing at home. The second-generation system offers built-in Wi-Fi, Bluetooth, USB, and wired Ethernet connectivity options. Patient and operator IDs can be captured at the time of testing. This allows the Coag-Sense PT2 meter to directly interface with POCT data management systems such as RALStm or TELCOR QML® without the expense of a docking station. The PT2 meter can store up to 2,000 test results and 500 QC results. Operator and QC lockout can be easily managed to ensure regulatory compliance in the hospital or clinic setting. An optional barcode scanner is available for easily entering patient and operator information.

The Coag-Sense PT2 meter is now commercially available.

About CoaguSense, Inc.

Based in Fremont, California, CoaguSense was founded in 2008 to bring more accurate and robust anticoagulation monitoring technology to both clinicians and patients. The company's lead product is the Coag-Sense PT/INR Monitoring System, which incorporates a novel direct micromechanical clot-detection technology. This proprietary technology emulates the World Health Organization (WHO) gold standard tilt-tube method while requiring only a very small blood sample. Direct clot-detection technology provides clinicians with the system reliability they demand and patients with the comfort of knowing that proper home testing can provide dependable results like a laboratory. In 2016, CoaguSense was acquired by i-SENS, Inc.?a leader in point-of-care diagnostic technology and manufacturing. Further information about CoaguSense can be found at www.coag-sense.com

Coag-Sense is a registered trademark of CoaguSense. All other trademarks are the property of their respective owners.

 

SOURCE CoaguSense, Inc.


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News published on 2 april 2019 at 09:14 and distributed by: