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Flobio Has Achieved Breakthrough Device Designation from U.S. FDA for Advanced Bleeding Risk Diagnostic Test

FloBio, a company specializing in medical diagnostics, has recently unveiled an important development: the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for their rapid bleeding risk diagnostic test. This designation signifies the FDA's acknowledgment of the potential of FloBio's device to revolutionize the diagnosis and treatment of critical and debilitating diseases.

FloBio's innovative test assesses an individual's blood clotting status and identifies the presence of Direct Oral Anticoagulants (DOACs), a widely used type of blood thinner. This diagnostic capability holds significant value for emergency and critical care clinicians, as it aids them in making well-informed decisions, particularly in managing serious bleeding, a prominent cause of preventable complications and fatalities within U.S. hospitals.

The popularity of DOACs has grown significantly, with millions of Americans relying on these drugs to manage conditions like atrial fibrillation and deep vein thrombosis. However, the use of DOACs can heighten the risk of bleeding and complicate emergency care. The absence of effective bedside diagnostics for assessing DOAC status has created challenges in the prevention and management of bleeding in various medical scenarios, including trauma, invasive surgeries, and strokes. Major bleeding events linked to blood thinners can result in mortality rates of up to 20% within 30 days, extended hospital stays, and increased readmission rates.

FloBio's cutting-edge precision point-of-care DOAC detection test is a groundbreaking solution that empowers emergency medical professionals to make informed decisions, including whether to administer drugs that reverse the effects of DOACs. Designed for in-vitro diagnostic applications, this automated hemodynamic assay offers a comprehensive evaluation of a patient's blood clotting status, including any anticoagulation due to DOACs. The innovative device platform combines hemodynamic flow and discrete clot activation to replicate the natural blood clotting process, delivering a swift and comprehensive assessment of DOAC drug effects at the patient's bedside.

The rapid detection of DOACs is pivotal for physicians, enabling them to make informed decisions about whether to initiate drug reversal for safer patient management. FloBio is encouraged by the FDA's recognition of their device's potential to significantly enhance the diagnosis and treatment of life-threatening diseases and conditions.


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