CoaguSense

What CoaguSense does

CoaguSense, Inc. is a Fremont, California-based medical technology company that designs, manufactures, and distributes the Coag-Sense PT/INR Monitoring System, a CLIA-Waived point-of-care and patient self-testing device for prothrombin time and International Normalized Ratio (INR) measurement in patients on warfarin-type anticoagulation therapy. The company is a wholly owned subsidiary of i-SENS, Inc. and operates with 51–100 employees under the CoaguSense legal entity. Its flagship product, the PT2 meter, uses patented Direct Clot Technology that mechanically lifts the fibrin clot from a reaction well to interrupt a light beam, miniaturizing the WHO mechanical tilt-tube gold standard for direct measurement of true prothrombin time. The technology avoids the secondary detection methods (such as impedance monitoring) used by competing point-of-care systems. Both Professional (clinic) and Patient Self-Testing (PST) versions share the same meter and consumables, enabling continuity between hospital/clinic and home testing.

The portfolio includes the PT2 meter, single-use PT test strips, control strips, lancets, sample transfer tubes, and an NFC Tag scanner that replaced the barcode-label system used in the prior PT1 meter. The PT2 delivers results in under one minute using a 10–12 µl capillary fingerstick sample, reports INR across 0.8–8.0, stores up to 2,000 patient results, and connects to EHR/LIS systems via Wi-Fi, Bluetooth, USB, and Ethernet through middleware platforms including AegisPOC, RALS, Clinisys Orchard, Siemens UniPOC, Siemens POCcelerator, TELCOR QML, and AQURE. In March 2026, CoaguSense announced the acquisition of DOASENSE GmbH's DOAC testing business, adding the DOAC Dipstick urine-based rapid test, DOASENSE Reader, and Control Solutions. These products hold IVDR-CE marks and are registered in the EU, UK, Australia, and Brazil, extending the platform into direct oral anticoagulant diagnostics.

Commercially, CoaguSense does not sell directly to consumers. Distribution runs through medical product distributors (Wilburn Medical, STAT Technologies) serving healthcare providers and patient self-testers, and Independent Diagnostic Testing Facilities (IDTFs) such as Lincare that facilitate Medicare-covered home INR monitoring for eligible patients (80% meter cost coverage and 100% supplies coverage after annual deductible). Reimbursement is tied to CPT Code 85610(QW) and DME code E-1399. The company sells primarily into two end-customer segments: anticoagulation clinics and healthcare professionals performing point-of-care testing, and motivated patient self-testers prescribed warfarin. Marketing efforts center on educational content (blog, white papers, training videos in English and Spanish), conference participation (ISTH, NDC, AC Forum Bootcamp), and listed connectivity on hospital middleware platforms.

Name

CoaguSense

Legal name

CoaguSense, Inc.

Website

https://coag-sense.com

Company type

Private

Founded year

2008

Operating status

Operating

Headcount range

51–100 employees

Short description

CoaguSense designs and manufactures the Coag-Sense PT/INR Monitoring System, a CLIA-waived point-of-care and patient self-testing device using patented direct mechanical clot detection. It serves US anticoagulation clinics, healthcare professionals, and warfarin patients, distributing exclusively through medical product distributors and IDTFs.

Ownership category

akta.pro rank

Product category

Point-of-Care Coagulation Diagnostics

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Measuring & Controlling Devices, Nec (3829)

akta.pro primary industry

Cardiac & Coagulation POCT (Troponin, BNP, INR/aPTT, D-dimer) (HLAHAOAC)

akta.pro secondary industries

Remote Diagnostics & Home Testing Devices (Connected POC/At-Home Diagnostic Readers) (HLAHACAL), Remote Diagnostics & Point-of-Care (Connected Testing, Home Lab Devices) (HLACAPAK), Hematology & Coagulation Diagnostics (HLAHAAAB)

Keywords

• Point-of-care coagulation monitoring
• PT/INR testing systems
• Warfarin monitoring devices
• Direct clot detection technology
• Patient self-testing meters

Headquarters

HQ city

Fremont

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B and B2C

Offering type

Hardware or Manufacturing

Cost components

Operations, Supply Chain, Personnel, Technology or R&D, Marketing or Sales

Go-to-market motion3 records

Distribution channels3 records

Marketing channels6 records

Core offering

CoaguSense researches, manufactures, and sells the Coag-Sense PT/INR Monitoring System, a portable point-of-care device that uses patented Direct Clot Technology to mechanically measure true prothrombin time (PT) and INR from a fingerstick blood sample. The system is offered in two distinct versions—the Professional System for anticoagulation clinics, hospitals, and point-of-care settings, and the Patient Self-Testing (PST) System for at-home use by motivated warfarin patients—and is complemented by single-use PT test strips, control strips, and connectivity to EHR and POCT data management systems.

Product overview

CoaguSense offers a focused portfolio of coagulation monitoring products centered on its PT2 PT/INR Monitoring System — a portable point-of-care device that uses patented Direct Clot Technology to measure true prothrombin time (PT) and INR for patients on warfarin. The PT2 system is available in both a Professional version (for clinics and point-of-care settings) and a Patient Self-Testing (PST) version (for motivated at-home users), with the same meter and strips usable across both settings. Accessories include single-use test strips, control strips, lancets, and sample transfer tubes, with an NFC Tag scanner replacing the prior PT1 barcode-label system. In 2026, CoaguSense announced the acquisition of DOASENSE GmbH's DOAC testing business (DOAC Dipstick, DOASENSE Reader, and Control Solutions), which will expand its portfolio beyond traditional warfarin monitoring into the rapidly growing Direct Oral Anticoagulant (DOAC) diagnostics market.

Differentiator

Problem solved

Functional benefit

Brands

• Coag-Sense PT2: The PT2 PT/INR Monitoring System with patented direct clot detection technology for point-of-care prothrombin time monitoring.
• DOAC Dipstick

Products and services

• Coag-Sense PT2 PT/INR Monitoring System A portable point-of-care prothrombin time (PT) and International Normalized Ratio (INR) monitoring system that uses patented Direct Clot Technology to mechanically detect clot formation and report true PT seconds in under one minute, based on WHO mechanical tilt-tube methodology. Used by healthcare professionals at point of care and by motivated patient self-testers at home.
• Coag-Sense PT2 PT/INR Professional System Professional-use configuration of the PT2 PT/INR monitoring system intended for healthcare professionals at the point of care to regularly monitor patients on warfarin-type anticoagulation therapy. Includes meter and required accessories; CLIA-Waived.
• Coag-Sense PT2 Patient Self-Testing (PST) System Patient self-testing version of the PT2 PT/INR monitoring system that enables motivated patients on warfarin to perform PT/INR tests at home using a 10–12 µl capillary whole blood fingerstick sample. Results can be communicated to providers via Wi-Fi, USB, or Bluetooth. Has 510(k) market clearance in the United States.
• Coag-Sense PT Test Strips and Control Strips Single-use test strips that work with the PT2 meter to perform prothrombin time tests using a 10–12 µl capillary whole blood sample from a fingerstick. Control strips are used for quality control testing. NFC-enabled strip packaging replaces the PT1 barcode label system.
• DOAC Dipstick First point-of-care urine-based test for detecting direct oral factor Xa and thrombin inhibitors (DOACs), providing qualitative results within 10 minutes. Acquired from DOASENSE GmbH as part of CoaguSense's expansion beyond warfarin monitoring into the DOAC diagnostics market.
• DOASENSE Reader Reader device for use with the DOAC Dipstick and Control Solutions, included in the DOASENSE GmbH DOAC testing business being acquired by CoaguSense.
• DOASENSE Control Solutions Quality control solutions used with the DOAC Dipstick and DOASENSE Reader, included in the acquisition of DOASENSE GmbH's DOAC testing business by CoaguSense.

Quantifiable outcome

• Twice the accuracy at 20% cost saving over typical alternative PT/INR meters
• +4 more outcomes

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration7 records

Feature7 records

Partnerships

One partnership is on record.

• DOASENSE GmbHcoreStrategic or Co-development Partner · 23 March 2026CoaguSense has entered into a definitive asset purchase agreement to acquire the DOAC testing business of DOASENSE GmbH, a German medical technology company based in Heidelberg specializing in Direct Oral Anticoagulant (DOAC) diagnostics. The acquisition includes DOASENSE's flagship DOAC Dipstick (first point-of-care urine-based test for DOAC detection, providing qualitative results within 10 minutes), the DOASENSE Reader, and Control Solutions. All products are IVDR-CE marked and registered in the EU, UK, Australia, and Brazil. The transaction is expected to close within 12 months, subject to customary closing conditions. This acquisition enables CoaguSense to expand beyond traditional Vitamin K Antagonist (warfarin) monitoring into the rapidly growing DOAC market.

Scale indicators5 records

Recent moves4 records

Expansion highlights5 records

Broad incumbents

• Abbott Point of Care: Abbott's i-STAT system is a broad POC diagnostics platform that includes PT/INR testing; CoaguSense integrates with Abbott's AegisPOC and RALS middleware, positioning Abbott as both a competitor and infrastructure provider.
• QuidelOrtho (Triage): QuidelOrtho's Triage platform is a broad POC diagnostic system with overlapping cardiovascular and anticoagulation monitoring applications, competing more broadly in the POC diagnostics landscape.

Emerging players

• DOASENSE GmbH: DOASENSE is the German DOAC diagnostics company whose DOAC Dipstick business is being acquired by CoaguSense; their point-of-care urine-based DOAC test expands CoaguSense's portfolio into the direct oral anticoagulant detection category.
• Biosynex: Biosynex is a European rapid diagnostics player with coagulation and cardiovascular POC products, relevant as an emerging competitor in international POC INR and anticoagulation monitoring markets.

Direct peers

• Helena Laboratories: Helena Laboratories manufactures POC coagulation testing equipment and reagents, competing with CoaguSense in clinical labs and physician offices performing PT/INR testing.
• Diagnostica Stago: Stago manufactures laboratory and POC coagulation testing systems, including the Stago Family of analyzers and the emBED line for POC INR testing, directly competing in coagulation diagnostics.
• Siemens Healthineers: Siemens offers the Xprecia Stride PT/INR meter for POC warfarin monitoring and provides UniPOC/POCcelerator middleware that CoaguSense integrates with, making them both a competitor and partner at the data layer.
• Roche Diagnostics: Roche's CoaguChek XS system is a leading point-of-care PT/INR meter and the most entrenched direct competitor to CoaguSense in both professional and patient self-testing markets worldwide.
• Werfen (Hemochron): Werfen's Hemochron Signature Elite is a hospital-based POC coagulation analyzer directly competing with CoaguSense PT2 in anticoagulation clinic and operating room settings.

Others

• i-SENS, Inc. i-SENS is CoaguSense's parent company and a major South Korea-based IVD manufacturer specializing in blood glucose monitoring, providing corporate backing, manufacturing infrastructure, and strategic oversight.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/channel/UCp_4FxEe2i-4LmKkQbR0rDQ
• LinkedInlinkedin.com/company/coagusense

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Subsidiaries1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A1 record

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about CoaguSense