The Coag-Sense PT/INR Monitoring System gains IVDR approval for home anticoagulation monitoring, marking the company’s European market entry.
CoaguSense Inc has received European approval for its Coag-Sense PT/INR Monitoring System for patient self-testing, expanding the device’s availability beyond its existing US market presence.
The approval comes in the form of an EU Technical Documentation Assessment Certificate under Regulation 2017/746 for in vitro diagnostic medical devices (Class C). The system is intended for use by properly selected and trained patients, or their caregivers, under physician supervision 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 US 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,” says Dr Seok-Won Lee, CEO of CoaguSense, in a release. “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.”
Technology Based on WHO Gold Standard
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 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.
The system incorporates direct micromechanical clot-detection technology that emulates the WHO gold standard tilt-tube method while requiring only a small blood sample. This proprietary technology aims to provide system reliability for clinicians and dependable results for patients conducting home testing.
Connectivity and Data Management Features
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 quality control lockout help ensure regulatory compliance in hospital and clinic settings. An optional barcode scanner streamlines entry of patient and operator information, while patient and operator IDs can be captured at the time of clinic testing.
The system enables direct integration with leading point-of-care testing data management systems such as AegisPOC, UniPOC, and POCcelerator without requiring an additional docking station.
CoaguSense, based in Fremont, California, was founded in 2008 and acquired by i-SENS Inc in 2016. The company focuses on anticoagulation monitoring technology for both clinicians and patients.
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