IntelliSep® is the first FDA-cleared diagnostic tool to assess cellular host response to aid in identifying emergency department patients with sepsis and contribute to rapid life-saving decisions
Cytovale®, a medical diagnostics company focused on advancing early detection technologies to diagnose fast-moving and immune-mediated diseases, announced today that its IntelliSep® test has received U.S. Food and Drug Administration (FDA) 510(k) clearance to aid in the early detection of sepsis for the approximately 30 million adult patients with signs and symptoms of infection who present to US emergency departments (ED) each year.
IntelliSep is a groundbreaking diagnostic tool that helps clinicians recognize sepsis and supports critical time-sensitive clinical decisions, providing test results in under 10 minutes. The first in a new class of ED-focused diagnostic tools that assess host response, the test is a simple, fast, and intuitive solution that provides actionable answers directly from a standard blood draw. IntelliSep categorizes patients into three bands according to their probability of sepsis, with Band 1 indicating low probability of sepsis and Band 3 indicating high probability of sepsis… Continue reading.
Cytovale, a medical diagnostics company focused on providing a faster, more insightful way to diagnose fast-moving and immune-mediated diseases, today announced the first enrollment in a clinical trial of the Cytovale system and IntelliSep test to aid in the rapid assessment of potential for sepsis in the emergency department (ED).
The trial, A Clinical Validation Solving the Question of Inflammation or Sepsis Hastily in the Emergency Department Protocol (CV-SQuISH-ED), is a multi-site, prospective study involving a minimum of 600 patients at multiple leading centers across the U.S. with the objective to demonstrate the performance of the IntelliSep test as a diagnostic marker of sepsis in the ED. The study’s primary endpoint is a comparison to sepsis as adjudicated by an independent panel of physicians, the gold standard for sepsis determination. Other endpoints include common severity of illness and utilization metrics… Continue reading.
WASHINGTON, D.C.— The American Institute for Medical and Biological Engineering (AIMBE) has announced the pending induction of Dino Di Carlo, Ph.D., Professor of Bioengineering, Department of Bioengineering, University of California, Los Angeles, to its College of Fellows. Dr. Carlo was nominated, reviewed, and elected by peers and members of the College of Fellows For outstanding contributions to inertial microfluidics that have revolutionized the biotechnology of cell separation.