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OrSense Ltd. issued the following announcement on May 14.
The OrSense NBM200 device provides painless, reliable and efficient hemoglobin measurements, allowing for the mandatory pre-donation hemoglobin screening to be completed without the traditional "finger prick". The CBER clearance announced today permits full scale commercialization of the NBM200 System into all US blood collection centers.
The NBM200 is the first ever non-invasive Hemoglobin measurement device cleared by the FDA/CBER for use in blood banks. The NBM200 was previously cleared by the FDA/CDRH for use in professional healthcare markets including hospitals, physician offices, and public health departments for measuring hemoglobin, pulse, and blood oxygen levels.
The NBM200 device has been used worldwide since 2014 by blood bank and plasma collection centers to screen millions of donors and in the U.S. the NBM200 has been used for over two years by OneBlood, one of the largest blood collection organizations in the U.S., under FDA special permit.
Chip Neff, President of OrSense U.S. said, "This new regulatory clearance will be welcome news for both blood donors and blood collection centers. The 'finger stick' is often mentioned by donors as the most painful part of the blood donation process. The OrSense NBM200 hemoglobin measurement is painless and represents a win/win for blood donors and blood bank organizations; it makes the blood donor experience more comfortable and provides for more efficient, lower cost operations for blood collection centers. The OrSense NBM200 will change the way pre-donation hemoglobin is measured by the U.S. blood bank industry."
Original source can be found here.
