The U.S. Food and Drug Administration has authorized a robotic device designed to automate blood draws in clinics and other outpatient settings. This is the first of its kind to receive this approval for outpatient use.
The device, called Aletta, is an autonomous system capable of drawing blood from a patient's arm. It uses near-infrared light and Doppler ultrasound to locate a suitable vein before proceeding with the rest of the procedure.
Once the vein is identified, the robot takes care of applying the tourniquet, inserting the needle, disposing of it, and applying a bandage to the puncture site. The entire process is automated following the initial intervention of trained personnel.
A trained phlebotomist must initiate the procedure and supervise the operation of the equipment while in use. However, a single person can control up to three Aletta units at the same time, which multiplies the capacity for care.
Response to Staff Shortages
Michelle Tarver, director of the FDA's Center for Devices and Radiological Health, noted that blood draws are among the most common medical procedures in the United States. “Patients may face delays due to a growing shortage of trained phlebotomists,” she stated.
The authorization was based on clinical data demonstrating that Aletta achieves success rates in blood draws comparable to or exceeding those of a human phlebotomist. These results were key to the regulatory approval.
