The FDA has approved the first automated device of its kind for ambulatory patients.
The U.S. Food and Drug Administration has approved a new product aimed at automating outpatient blood draws. Aletta is an autonomous robotic device capable of drawing blood from a patient’s arm. It uses near-infrared light and Doppler ultrasound to identify a vein, then automates other processes of a blood draw, such as applying a tourniquet, inserting and removing a needle, and applying a bandage to the patient. A trained phlebotomist must begin the procedure and supervise the device during use, but a single person can monitor up to three Aletta robots at a time.
“Blood draws are one of the most commonly performed medical procedures in the United States, but patients may face delays due to a growing shortage of qualified phlebotomists.” said Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health. Aletta’s approval was granted based on clinical data showing that she was able to perform successful blood draws at rates comparable to or better than a phlebotomist.
While Aletta may have FDA approval, it’s not yet clear when we’ll actually start seeing them in doctors’ offices.
