DrawBridge Health has earned the CE Mark for its OneDraw test system, a device that collects blood samples from the upper arm for hemoglobin A1C testing without the need for a traditional hypodermic needle.
The device is placed on the patient’s skin and draws blood using tiny lancets and vacuum suction, doing away with the need to puncture a patient’s vein with a needle. The sample is stored in a removable cartridge and plastic cassette that can be shipped to a laboratory for testing.
The company plans to launch the device in Europe this year. It previously received FDA 510(k) clearance.