Drawbridge Health Announces CE Mark for the OneDraw™ A1C Test System
Menlo Park, CA, USA – February 4, 2020 – Drawbridge Health today 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 OneDraw A1C Test System is intended for the collection and stabilization of blood and measurement of HbA1c levels for monitoring the long-term control of blood sugar (glucose) in adults with diabetes.
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.
About Drawbridge Health
Founded in 2015 by GE Ventures and GE Healthcare, Drawbridge Health is a healthcare technology company focused on reinventing the blood draw experience, enabling comfortable convenient blood sample collection anytime and anywhere. By integrating engineering and proprietary chemistries, Drawbridge is developing a people-friendly system for collecting and stabilizing blood samples, opening new doors to enable access to important health information. For more information, please visit www.drawbridgehealth.com.
 Data presented at the 2019 ADA annual conference.