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Medical Devices / Submissions and Approvals

Haemonetics Earns Expanded Indication for Hemostasis Analyzer

May 16, 2019
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The FDA granted Haemonetics 510(k) clearance for its TEG 6s Hemostasis Analyzer System, expanding the device’s medical indication for use in adult trauma situations.

The device, which is used to determine a patient’s hemostasis condition in lab or point-of-care settings, is the first cartridge-based system in the U.S. cleared to evaluate the hemostasis condition of adult trauma patients.

The TEG 6s system is able to generate test results in ten minutes and avoids the complicated preparations typically associated with traditional blood tests.

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