FDA Authorizes Aletta Robotic Blood Draw Device

The U.S. United States — Food and Drug Administration (FDA) has granted marketing authorization to Vitestro for the Aletta, the first standalone robotic device capable of drawing blood from a patient's arm without hands-on operator intervention. The device is authorized for use in adults in outpatient settings and must be operated under the oversight of a trained phlebotomist, who can supervise up to three Aletta devices simultaneously. The Aletta autonomously performs the blood draw process, including locating a vein using near-infrared light and Doppler ultrasound, applying a tourniquet, preparing the skin, inserting and disposing of the needle, changing collection tubes, and placing a bandage. The authorization is based on clinical data showing successful blood draw rates comparable to or better than trained human phlebotomists across a broad range of patients. The FDA granted the authorization through the De Novo pathway, establishing special controls for the device. This approval aims to address the growing phlebotomist shortage in the U.S. and improve patient access to blood draws.