Entegrion Announces CE Mark for Point of Care System for Blood Coagulation Monitoring.
Regulatory clearance makes Entegrion’s innovative point of care diagnostic instrument for viscoelastic coagulation testing available to clinicians in Europe.
DURHAM, N.C. (PRWEB) January 19, 2018 — Entegrion, Inc. today announced that it has achieved CE mark for the Company’s portable coagulation monitoring system (“PCM”) for use in clinical settings for the viscoelastic measurement of patient whole blood coagulation and hemostasis.
The CE marking signifies Entegrion’s declaration that the PCM complies with the stringent quality, safety, and performance standards and controls set by the European In Vitro Diagnostics Directive (98/79/EC), and enables the marketing of the PCM system in the European Union. “We are extremely pleased about the clinical results and performance that the PCM has demonstrated, and believe the ability to now offer a true point of care and portable viscoelastic coagulation test will significantly improve patient care and impact clinical outcomes,” said Jack Mowell, Executive Chairman at Entegrion.
Designed for ease of use and portability, the PCM offers a near patient and fully automated whole blood result without the need for sample pre-treatment, reagents or sample transfer to the clinical laboratory. Within minutes, a clotting result will begin to be displayed at the patient side, allowing the attending physician to quickly take action on critical pathways important in emergency care, critical care and surgical procedures.
Entegrion’s novel point of care instrument brings a cost effective and fully automated viscoelastic coagulation solution to patient care, making this important diagnostic offering more broadly accessible to clinicians.
Entegrion is a privately held life sciences company developing innovative solutions for the clinical diagnosis and treatment of conditions resulting in the need for hemorrhage control or management of hemostasis. In addition to the commercial launch of its PCM, a next generation point of care viscoelastic testing system, the Company is engaged in the clinical development of a pooled, pathogen reduced dehydrated human plasma product for transfusion (Resusix) intended to overcome the storage and safety limitations of fresh frozen plasma. Resusix is being developed in conjunction with the U.S. Department of Defense.
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