Novel Viscoelastic Coagulation Monitor (VCM) Granted FDA Breakthrough Designation for Assessing Preterm Neonates

VCM to be Used to Assess Coagulation Status from Whole Blood of Preterm Neonates Aged 28 or More Weeks, Full Term and Newborns up to Six Months Post-Birth

DURHAM, NC, UNITED STATES, May 27, 2025 /EINPresswire.com/ -- Entegrion, Inc., a leading developer of innovative solutions for clinical diagnosis and management of hemostasis, announced today that the VCM™, viscoelastic coagulation monitor, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) to assess coagulation status using native whole blood collected via standard venipuncture or heel sticks from preterm neonates older than 28 weeks, full-term neonates, and newborns up to six months post-birth. The Breakthrough Device Designation allows Entegrion to work collaboratively with the FDA to develop the first-in-class diagnostic solution for assessing coagulopathies in neonates.

Christopher Rumana MD, Chairman of the Board at Entegrion, stated, “Entegrion is excited to have the ability to collaborate with the FDA to create a diagnostic solution tailored to neonatal needs.”

When the marketing authorization application is approved “Entegrion will offer for the first time in the United States a diagnostic test specific to this extremely vulnerable patient population.” said Bert Valada, President and CEO of Entegrion. “Our CE marked whole blood heel stick diagnostic test gives the care giver a global understanding of a neonate hemostasis condition patient side and is currently demonstrating improved patient outcomes in Europe.”

About the Viscoelastic Coagulation Monitor (VCM)
The Entegrion VCM is a compact, portable device that performs a viscoelastic analysis of the coagulation-fibrinolysis process utilizing glass surface activation of untreated whole blood. The wide surface area of contact between the blood and the glass inside the cartridge accounts for the rapid initiation of clotting, eliminating the need for activating factors. VCM has made viscoelastic measurements of the hemostasis of whole blood samples rapid and accurate at the site of patient care. The VCM™ system is robust, reliable, totally automated and easy to use. It has demonstrated the ability to be used in transit, harsh and austere environments, and acute care settings, taking a once complex diagnostic test to the site of trauma.

About Entegrion
Entegrion is a life sciences development company that is focused on improving the safety and availability of blood diagnostics. Many of Entegrion’s advances in diagnostics are based on close collaborations with leading medical research institutions. Visit www.entegrion-vcm.com for more information.
MEDIA CONTACT: Info@entegrion-vcm.com

Bert Valada
Entegrion, Inc.
+1 919-536-1500
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