FDA authorizes Aletta autonomous robotic blood collection device

The US Food and Drug Administration (FDA) has authorized Aletta, the first autonomous robotic phlebotomy device (ARPD) designed to perform blood draws from a patient's arm without direct manual intervention during the procedure. Developed by the Dutch company Vitestro, the system is intended for use on adult patients in outpatient settings.

Aletta utilizes near-infrared light and Doppler ultrasound technology to locate suitable veins and distinguish them from arteries. Once a vein is identified, the device autonomously manages the procedure, including applying a tourniquet, preparing the skin, inserting the needle, collecting samples, changing tubes, and applying a bandage. The FDA noted that the device will not initiate the procedure if a suitable vein is not found.

While the device operates autonomously, it requires supervision by a trained phlebotomy professional. One technician can oversee up to three Aletta devices simultaneously. Clinical data analyzed by the FDA indicated that the robot achieved success rates comparable to or higher than trained phlebotomists, with adverse events being rare and generally mild. The technology is expected to help mitigate challenges related to shortages of specialized medical personnel.