The FDA has approved the first-of-its-kind automated device for outpatient settings.
The US Food and Drug Administration has approved a new product aimed at automating blood draws in outpatient situations. Aletta is a standalone robotic device capable of drawing blood from a patient’s arm. It uses near-infrared light and Doppler ultrasound to identify a vein and then automates the other processes of a blood draw, such as applying a tourniquet, inserting and disposing of a needle and placing a bandage on the patient. A trained phlebotomist must begin the procedure and oversee the device while it is in use, but a single person can monitor up to three Aletta robots at once.
“Blood draws are one of the most commonly performed medical procedures in the United States, yet patients may face delays due to a growing shortage of trained phlebotomists.” said Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health. The approval for Aletta was granted based on clinical data showing it was capable of successful blood draws at rates comparable to or better than a phlebotomist.
While Aletta may have FDA approval, there’s no word yet on when we’ll actually start seeing these in doctors’ offices.
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