www.fdanews.com/articles/191326-fda-clears-orsenses-hemoglobin-measurer-for-blood-bank-use
FDA Clears OrSense’s Hemoglobin Measurer for Blood Bank Use
May 16, 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.