Aug. 20, 2026—The U.S. Food and Drug Administration authorized Vitestro’s Aletta, the first standalone robotic device that can draw blood from a patient’s arm without hands-on operator intervention. It is authorized for use in adults in outpatient settings and must be operated under the oversight of a supervisor trained in phlebotomy.
The Aletta is designed to perform each step of the blood draw autonomously. A trained phlebotomist initiates each session and remains available to respond to any issues. The device guides the patient to position their arm, after which the patient or supervisor presses a button to start the blood draw. The Aletta then uses near-infrared light and Doppler ultrasound to locate a suitable vein and tell it apart from arteries; however, if no appropriate vein is found, the device will not attempt the procedure. Once a vein is identified, the Aletta applies a tourniquet, prepares the skin, draws the blood, and applies a bandage. The supervising phlebotomist confirms that collection tubes are filled in the correct order and verifies that all tubes are adequately full following the procedure.
The Aletta is designed with layers of patient safety in mind. It continuously applies disinfectant to the skin during the ultrasound scan. If a patient moves too much during the procedure, the needle automatically detaches and the draw stops. Additional onboard sensors can pause the procedure and alert the supervisor if other unsafe conditions are detected.
One phlebotomist can oversee up to three Aletta devices at the same time, which may help address the phlebotomist shortage in the U.S., the FDA said in its press release.