FloBio, a distinguished player in the medical diagnostics arena, unveiled a groundbreaking development today. The U.S. Food and Drug Administration (FDA) has granted FloBio's rapid bleeding risk diagnostic test the esteemed Breakthrough Device Designation. This recognition highlights the potential of the device to bring about a transformative shift in the diagnosis and treatment of life-threatening or irreversibly debilitating diseases and conditions.

FloBio's innovative test centers on the evaluation of a patient's blood clotting status and, crucially, their current usage of Direct Oral Anticoagulants (DOACs), a class of widely prescribed blood-thinning medications. This valuable information has the potential to empower emergency and critical care clinicians, allowing them to make well-informed decisions concerning strategies for reversing the effects of these drugs, with the ultimate aim of reducing the risk of severe bleeding— a significant cause of avoidable complications and fatalities in U.S. hospitals.

DOACs are highly effective and are commonly prescribed for managing conditions such as atrial fibrillation and deep vein thrombosis. However, their use can significantly elevate the risk of bleeding and complicate emergency medical care. Prior to this development, clinicians faced the challenge of lacking effective bedside diagnostics to accurately assess a patient's DOAC status.FloBio's point-of-care DOAC detection test effectively addresses this critical need, putting the essential tools into the hands of emergency medical professionals. This empowers them to make informed decisions, including the administration of drugs designed to reverse the effects of DOACs.

The distinctive feature of this novel device lies in its capacity to blend hemodynamic flow and discrete clot activation, accurately emulating the physiological process of blood clotting. The outcome is a swift and comprehensive evaluation of a patient's DOAC drug status, conducted right at their bedside. This capability holds the promise of making a substantial difference in emergency medical scenarios, where time is often a critical factor.

Source:prnewswire.com