CoaguSense, Inc.

CoaguSense, Inc. manufactures and sells the Coag-Sense® PT/INR Monitoring System, an in vitro diagnostic (IVD) device designed for prothrombin time (PT) and International Normalized Ratio (INR) testing in patients on warfarin anticoagulation therapy. The system uses direct mechanical clot detection—mechanically lifting the fibrin clot to interrupt a light beam—replicating the gold-standard WHO tilt-tube methodology in a compact, point-of-care format suitable for anticoagulation clinics and home patient self-testing. The platform includes a portable meter, single-use PT and control strips, and accessories. Key differentiators include rapid results, direct mechanical detection (avoiding impedance-based limitations), and digital connectivity (Wi-Fi, Bluetooth, USB, Ethernet) for integration with EHR systems, POCT data management platforms (TELCOR, RALS), and testing service providers. The Coag-Sense® system is used by professionals and patients requiring reliable PT/INR monitoring with results correlating well to reference methods. The company provides training resources, technical support, and clinical evidence including peer-reviewed publications demonstrating reliability across patient populations.