FDA approves Aletta robotic system for autonomous blood draws

The U.S. Food and Drug Administration (FDA) has granted De Novo authorization to Aletta, an autonomous robotic system developed by the Dutch company Vitestro. The device is designed to perform blood draws on adult patients in outpatient settings with minimal human intervention.

To locate a suitable vein and distinguish it from an artery, the Aletta system utilizes a combination of near-infrared light and Doppler ultrasound. If a suitable vein is not identified, the system is programmed to abort the procedure automatically. Once a vein is located, the robot performs several steps: applying a tourniquet, disinfecting the skin, inserting the needle, collecting the blood samples, discarding the needle, and applying a bandage.

While the device operates autonomously, the FDA requires a trained phlebotomist to supervise the process. The professional is responsible for initiating the procedure, ensuring collection tubes are filled in the correct order, and verifying sufficient blood volume. This technology aims to address the shortage of trained phlebotomy professionals in the United States, as a single technician can oversee up to three Aletta devices simultaneously.