CoaguSense (Fremont, Calif.) recently announced that it has received FDA 510(k) clearance for its second-generation prothrombin time/international normalized ratio (PT/INR) monitoring system.
The Coag-Sense PT2 meter is designed for monitoring patients who are on Coumadin. It features a clot-detection technology that is small enough to be carried in a lab coat pocket and connected wirelessly to a 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 wats to export the test results into virtually any data management system,” Douglas Patterson, president and CEO of CoaguSense, said in a press release. “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 device was cleared for professional use in CLIA-waived setting and patient self-testing at home. It offers built-in WiFi, Bluetooth, USB and wired Ethernet connectivity options. Patient and operator IDs are able to be captured while testing, allowing the device to be used with POCT data management systems like RALS or TELCOR QML without the need for a docking station. The meter can also store up to 2,000 test results and 500 QC results.
