CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
November 2023—FloBio announced that the FDA has granted breakthrough device designation for its rapid bleeding risk diagnostic test. The point-of-care test is designed for in vitro diagnostic use to determine blood clotting status and whether a patient is on a direct oral anticoagulant.
The automated hemodynamic assay aims to give a complete picture of a patient’s blood clotting status, including anticoagulation caused by DOACs. The novel device platform combines hemodynamic flow and discrete clot activation to mimic physiological blood clotting and produce a comprehensive DOAC drug assessment at the patient’s bedside.
FloBio, 332-217-5334