The US Food and Drug Administration has authorised Aletta, the first standalone robotic device that can draw blood from a patient’s arm without operator intervention.The device is authorised for use in adults in outpatient settings and must be operated under the oversight of a supervisor trained in phlebotomy. One phlebotomist can oversee up to three Aletta devices at the same time, which may help address the current shortage of phlebotomists in the US.Michelle Tarver, Director of the FDA’s Center for Devices and Radiological Health, said, “Blood draws are one of the most commonly performed medical procedures in the United States, yet patients may face delays due to a growing shortage of trained phlebotomists.” The Aletta autonomously handles each step of the blood draw, while a trained phlebotomist initiates each session and remains available to respond to any issues throughout. 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. If no appropriate vein is found, the device will not attempt the procedure.Once a vein is identified, Aletta proceeds through the remaining steps on its own: applying a tourniquet, preparing the skin, inserting and disposing of the needle, changing collection tubes and placing a bandage. The supervising phlebotomist confirms that the collection tubes have been filled in the correct order and verifies that all tubes are adequately filled following the procedure.The Aletta is designed with multiple layers of patient safety in mind. The device continuously applies disinfectant to the skin during an ultrasound scan. Between patients, the device is cleaned by a trained professional. 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.The FDA’s authorisation is based on clinical data that demonstrated that the Aletta achieves successful blood draw rates comparable to, or better than trained human phlebotomists. This was demonstrated across a broad range of patients, including those with varying health statuses, those who self-reported having difficult vein access and those with varying skin tones. Device-related adverse events were uncommon and mild. The FDA granted marketing authorisation for the Aletta to Vitestro through the De Novo pathway, a regulatory pathway for low- to moderate-risk devices of a new type.Published on August 24, 2026