Aletta promises greater precision and consistency, but the procedure still requires professional supervision.
UTRECHT, NETHERLANDS
The United States Food and Drug Administration has authorized Aletta, a robotic device developed by Dutch medical-technology company Vitestro to perform routine blood draws. It is the first standalone system of its kind permitted in the United States and can complete most stages of the procedure without direct physical intervention from a phlebotomist.
Aletta combines near-infrared imaging, conventional ultrasound and Doppler ultrasound to locate a suitable blood vessel. Doppler technology analyses blood flow and helps the device distinguish a vein from an artery. If the system cannot confidently identify an appropriate vein, it does not insert the needle and refers the patient to a healthcare professional.
After selecting the puncture site, the robot applies a tourniquet, disinfects the skin and inserts the needle with submillimetre precision. It can also change and handle collection tubes, remove and dispose of the needle and place a bandage over the puncture. Sensors interrupt the procedure if the patient moves excessively or another potentially unsafe condition is detected.
In clinical testing, Aletta achieved a 94.5 percent first-attempt success rate. Approximately 90 percent of participants described the discomfort as equal to or lower than that experienced during a conventional manual blood draw. These results indicate that automation could reduce repeated needle insertions, although they do not establish that the procedure is completely free of risk.
A trained phlebotomist must initiate every session, remain available to intervene and verify that the tubes have been filled correctly. Vitestro expects one professional eventually to supervise as many as three devices simultaneously. The technology is intended to address staffing shortages and standardise a highly repetitive medical procedure, supporting healthcare workers rather than eliminating the need for their clinical judgement.
Hechos que no se doblan. / Facts that do not bend.