PR Newswire04.03.19
CoaguSense Inc., a subsidiary of i-SENS, announced t 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.
"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 RALS 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.
"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 RALS 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.
