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Medical Devices / Submissions and Approvals

FDA Clears OrSense’s Hemoglobin Measurer for Blood Bank Use

May 17, 2019
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OrSense earned the FDA’s 510(k) clearance for the use of its NBM200 product in blood banks, a device that measures a patient’s hemoglobin levels without the need for finger pricking.

The non-invasive device conducts mandatory hemoglobin screening that is required prior to donating blood at a blood bank.

The measurement device was previously cleared by the agency for hospitals, doctor’s offices and public health departments for measuring blood oxygen, pulse and hemoglobin levels.

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