FDA Grants Market Clearance for the OrSense NBM200; the First Noninvasive Hemoglobin System Cleared for Use in Blood Donation Centers
Petach Tikva, Israel, May 14, 2019 (Newswire.com) - OrSense Ltd., a leading developer of systems for non-invasive measurements of Hemoglobin, today announces that its NBM200 non-invasive Hemoglobin measurement device has received FDA/CBER 510(K) clearance for use in blood banks.
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.”
OrSense is a medical device company developing and marketing non-invasive hemoglobin, pulse, and oximetry measurement systems based on its proprietary Occlusion Spectroscopy technology. OrSense’s systems have been successfully installed in dozens of blood donation and plasma collection facilities worldwide. More recently Orsense has begun offering the NBM200 to other professional healthcare market segments including selected physician clinics and anemia screening locations. For additional information, please visit OrSense’s website at www.orsense.com.
Guy Greitser, OrSense Ltd.
Source: OrSense Ltd.
Categories: Hematology/Blood Disorders