FloBio Receives the FDA’s Breakthrough Device Designation for its Bleeding Risk Diagnostic Test

Penn Spinout and PCI Ventures portfolio company FloBio LLC received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its rapid bleeding risk diagnostic test.

FloBio’s test determines blood clotting status and identifies whether a patient is on popular blood thinners called Direct Oral Anticoagulants (DOACs), which can elevate bleeding risk and complicate emergency care.

The information provided by FloBio’s test would help emergency and critical care clinicians make more informed treatment decisions about drug reversal to reduce serious bleeding, which has been a major cause of preventable complications and death in US hospitals across the country.

To learn more about FloBio and their innovative technology, read the full press release here.

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