FDA authorizes autonomous robotic blood-drawing device

The U.S. Food and Drug Administration (FDA) has authorized Aletta, an autonomous robotic device designed for blood collection. Developed by the Dutch startup Vitestro, the device is intended to assist laboratories and hospitals in managing staffing shortages among trained phlebotomists.

The robot utilizes near-infrared light and real-time Doppler ultrasound imaging to identify suitable veins while ensuring it avoids arteries. Once a vein is located, the device autonomously performs several steps, including applying a tourniquet, sanitizing the skin, inserting the needle, swapping collection tubes, and applying a bandage.

While the device operates autonomously, it requires supervision by a trained phlebotomist. A professional must initiate the session, oversee the process, ensure tubes are filled in the correct order and volume, and disinfect the machine between uses. A single phlebotomist can supervise up to three Aletta devices simultaneously.