FREMONT, Calif., Sept. 02, 2025 (GLOBE NEWSWIRE) -- CoaguSense, Inc., a subsidiary of i-SENS (KOSDAQ:099190), today announced that it has received approval for the sale of the Coag-Sense® PT/INR Monitoring System for patient self-testing in Europe.
The approval was granted in the form of an EU Technical Documentation Assessment Certificate under Regulation (EU) 2017/746 (IVDR) for in vitro diagnostic medical devices (Class C). The device is intended for use by properly selected and trained patients, or their caregivers, under the supervision of a treating physician to monitor oral anticoagulation therapy in patients receiving warfarin-type anticoagulants.
"CoaguSense received Clinical Laboratory Improvement Amendments (CLIA) Waiver for patient self-testing in the U.S. in 2010, and we have been steadfast in our mission to help people with coagulation disorders live healthier lives with actionable information at the point of care," said Dr. Seok-Won Lee, CEO of CoaguSense. "We are very excited that we now have the opportunity to extend this benefit to patients in Europe. From a business perspective, this approval marks an important milestone in our global expansion efforts."
The Coag-Sense® PT/INR Monitoring System is based on the same mechanical principle as the World Health Organization's gold standard manual tilt-tube technique (MTT), used to this day for calibration of all commercial thromboplastins. The system previously received FDA 510(k) clearance for both professional use in CLIA-waived settings and for patient self-testing at home.
Designed for both clinical and home environments, the system offers built-in Wi-Fi, Bluetooth, USB, and wired Ethernet connectivity. Patients self-testing at home can transmit results in real time to dedicated software platforms through smart Apps or cellular Hubs. Features such as Operator and QC lockout help ensure regulatory compliance in hospital and clinic settings, and an optional barcode scanner streamlines entry of patient and operator information. Patient and Operator IDs can be captured at the time of clinic testing, while enabling direct integration with leading POCT data management systems such as AegisPOC, UniPOC®, and POCcelerator® without the added cost of a docking station.
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
Coag-Sense is a registered trademark of CoaguSense. All other trademarks are the property of their respective owners.
SOURCE CoaguSense, Inc.
CONTACT:
Jinheung Kim
jkim@coagusense.com
+1 510 335 8481
