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January 5, 2022

Werfen secures 510(k) clearance from US FDA for blood hemostasis system

GEM Hemochron 100 is intended to help improve workflow and patient management decisions.

By Hasini Devarasetti

Werfen has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its GEM Hemochron 100 whole blood hemostasis testing system.

The system uses Hemochron technology and provides activated clotting time (ACT) results in minutes.

It is intended to help improve workflow and patient management decisions, Werfen said.

At present, the system is in clinical use in several European countries. It will be commercialised in the US early in the year.

The GEM Hemochron 100 system can help in optimising heparin dosing and enables rapid initiation of critical procedures by delivering ACT results more quickly than traditional systems.

Werfen hemostasis and acute care diagnostics, worldwide marketing and service vice-president Remo Tazzi said: “In critical procedures, such as cardiac surgery, accuracy, speed and reliability of whole blood hemostasis testing to guide heparin therapy is paramount – and the GEM Hemochron 100 delivers.

“This allows clinicians to make informed patient management decisions at the point of care, helping improve patient outcomes in the cardiovascular operating room and other acute care settings.”

The system is designed for invasive procedures that require heparin dose adjustment, in cases where quick and accurate ACT results are essential.

Testing flexibility is offered in different clinical settings that can include cardiac catheterisation labs, intensive care units, cardiovascular operating rooms and electrophysiology labs.

The GEM Hemochron 100 ACT test provides a maximally ACT that helps in supporting the existing clinical practice guidelines.

Additionally, the system enables automatic, wireless, bidirectional data transmission and remote configuration with the new integration of Wi-Fi capabilities.

Last month, Sight Sciences received 510(k) clearance from the US FDA for its TearCare System for the treatment of meibomian gland dysfunction (MGD).

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