Aletta: The Robot That Can Now Draw Blood Without Human Hands

The U.S. Food and Drug Administration (FDA) has officially approved Aletta, a robotic device that can now draw blood from patients without direct human intervention. This marks a significant step in the automation of routine medical procedures, as Aletta becomes the first stand-alone robotic device authorized for autonomous blood draws.

The FDA granted marketing authorization through its De Novo pathway, a route reserved for novel devices without an existing legally marketed equivalent. Vitestro, a Dutch medical technology company, developed Aletta, and its application for approval was submitted in September 2025 and approved on August 19, 2026.

Aletta combines robotic precision with human supervision during the blood collection process. It utilizes near-infrared imaging, ultrasound, and Doppler ultrasound to locate and identify suitable veins, ensuring the needle is inserted into a safe and appropriate vessel. The supervising professional remains present throughout the procedure, responsible for monitoring the process, ensuring proper tube filling, and verifying the collected blood volume.

While Aletta can perform the technical aspects of venipuncture autonomously, it cannot be used for blood donation purposes. The FDA emphasizes that Aletta is designed to alleviate staffing shortages and improve the efficiency of blood collection services, without compromising safety standards. The device has undergone rigorous testing, including clinical data from diverse patient populations, to ensure its accuracy and safety.