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Medical Devices / Submissions and Approvals

FDA Clears OrSense’s Hemoglobin Measurer for Blood Bank Use

May 17, 2019

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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