Drawbridge Health Announces CE Mark for the OneDraw A1C Test System
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rawbridge Health announced that it has completed the CE Mark process for the OneDraw A1C Test System - a novel, easy to use device that enables blood to be drawn comfortably and conveniently by a healthcare professional (HCP).
The CE Mark follows the August 2019 510(k) clearance of the OneDraw A1C Test System from the Food and Drug Administration (FDA) in the United States. The CE Mark represents another milestone for Drawbridge Health toward expanding our global reach to more patients and more HCPs across the European Union and other CE Mark geographies, said Lee McCracken, CEO at Drawbridge Health.
The Future of Blood Collection and Testing
The OneDraw Blood Collection Device is a small, single-use device that draws, collects, and stabilizes a capillary blood sample from the upper arm. Instead of using a traditional hypodermic needle to puncture a patient's vein, the device is placed on the skin and blood is gently collected using tiny lancets and a light vacuum suction.
OneDraw has been designed so that once collected, a blood sample is contained within a removable cartridge, stabilized in a plastic cassette, and shipped to a designated certified clinical laboratory for HbA1c testing (in the United States, a OneDraw sample can be shipped via regular mail). The entire process is convenient, comfortable and reliable.1
Drawbridge Health's Continued Growth
The CE Mark and earlier 510(k) clearance of the OneDraw A1C Test System are just the initial regulatory steps toward Drawbridge Health's global initiative to improve health care through more accessible blood sampling. We anticipate the product's European debut to begin in select countries in 2020, as we continue to expand our commercialization activities - including the establishment of our new London office, adds Lee McCracken, CEO at Drawbridge Health.
For more information on Drawbridge Health and OneDraw, connect with us on Facebook and LinkedIn or visit www.drawbridgehealth.com.
✔️ Drawbridge Health Announces CE Mark for the OneDraw A1C Test System
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