FDA clears first autonomous robot for drawing blood in outpatient clinics

The U.S. Food and Drug Administration has granted clearance to Aletta, a robotic system designed to perform venipuncture in outpatient environments. The device combines near-infrared light and Doppler ultrasound to pinpoint a suitable vein, then automates the steps of a blood draw, including tourniquet placement, needle insertion, needle disposal and bandaging. While a trained phlebotomist must initiate the process and monitor the robot, a single operator can manage up to three Aletta units simultaneously.

Approval was based on trial results indicating the robot achieves draw success rates at least on par with, and sometimes exceeding, those of human phlebotomists. Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health, highlighted the technology’s potential to alleviate delays caused by a shortage of skilled phlebotomists. The clearance does not specify when the robots will become available in clinics.