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Point-of-Care Blood Clotting Diagnostic Device

CHALLENGE: Design and develop a portable, cost-effective blood-testing device.

SERVICES: Insights, Design, Engineering, IoT Enablement, Prototyping, Commercialization

INDUSTRY RECOGNITION: Featured at the annual American Society of Hematology and Oncology (ASH) Conference 

SUCCESS: Received Breakthrough Device designation from the FDA

 

Collecting blood for clotting analysis with the Clot Chip Sensor

 

The ClotChip® is a groundbreaking portable blood-testing device developed by XaTek in collaboration with medical device innovation partner Nottingham Spirk using advanced technology licensed from Case Western Reserve University. It serves as a cost-effective blood analytics sensor designed to assess blood coagulability accurately and rapidly at the point of care, making it a valuable tool for healthcare professionals.

The emergence of Target Specific Oral Anticoagulants (TSOACs) has improved the treatment of cardiovascular and post-surgical conditions. However, monitoring a patient's coagulability while on TSOAC drugs is crucial to ensure their safety and adjust medication dosage if necessary. The ClotChip addresses this need by providing a point-of-care solution to effectively monitor a patient's ability to clot when taking TSOAC drugs.

XaTek and Nottingham Spirk collaborated to research, conceptualize, design, engineer, build and test handheld units that incorporate the ClotChip sensor technology. Our services included the integration of user interface/user experience (UI/UX) design and the enablement of Internet of Things (IoT) connectivity. These handheld diagnostic devices are specifically designed for ease of use, thus can be adapted to diverse market needs.

The ClotChip has received the prestigious Breakthrough Device designation from the U.S. Food and Drug Administration (FDA), acknowledging its innovative nature and significant contributions to healthcare.

Connectivity Enables Remote Data Access

The ClotChip sensor is a connected, IoT-enabled device equipped with Wi-Fi and Bluetooth capabilities. This connectivity allows researchers and physicians to remotely access the data generated by the sensor, which is stored in the cloud. A microcontroller within the device interprets the data and displays the results on the screen, enabling healthcare providers to make informed decisions regarding patient care. Additionally, this innovative diagnostic solution is designed to be low-cost and utilizes disposable test strips, enhancing its accessibility and usability.

The exceptional capabilities of the ClotChip have garnered recognition within the medical community. It has been featured at the annual American Society of Hematology and Oncology (ASH) Conference, showcasing its effectiveness and potential impact on patient care. 

ClotChip Hand-Held Blood Clotting Diagnostic Device

 

ClotChip medical product design renderings

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