FDA authorization of Aletta robotic blood-drawing device

The U.S. Food and Drug Administration (FDA) has authorized Aletta, an autonomous robotic phlebotomy device (ARPD) developed by the Dutch startup Vitestro. Designed to assist with medical staffing shortages, the device is intended for use on adult patients in outpatient settings.

The system utilizes near-infrared light and real-time Doppler ultrasound imaging to identify suitable veins while avoiding arteries. Once a vein is located, the device autonomously performs the procedure, which includes applying a tourniquet, sanitizing the skin, inserting the needle, swapping collection tubes, and applying a bandage. The FDA noted that the device will not initiate the procedure if a suitable vein cannot be found.

While the device operates autonomously, it requires supervision by a trained phlebotomist, who must initiate the session, oversee the process, and disinfect the machine. A single professional can supervise up to three Aletta devices simultaneously. Clinical data indicated that the robot achieved success rates comparable to or higher than trained phlebotomists, with adverse events being rare and generally mild.