The U.S. Food and Drug Administration has authorized Aletta, the first standalone robotic device capable of drawing blood from a patient’s arm without hands on intervention by a healthcare professional. Developed by Vitestro, the system is authorized for adults in outpatient settings and operates under the supervision of a trained phlebotomist.
The authorization could have implications for one of healthcare’s most frequently performed procedures. According to the FDA, shortages of trained phlebotomists can contribute to delays in blood collection. With Aletta, a single phlebotomist can supervise up to three devices simultaneously.
Automated blood collection
The phlebotomist remains responsible for initiating and supervising the procedure, but Aletta autonomously performs most of the blood draw. After the patient positions their arm, the procedure is started by the patient or supervisor. Aletta uses near infrared light and Doppler ultrasound to identify a suitable vein and distinguish it from arteries. If the system cannot identify an appropriate vein, it will not attempt to insert the needle.
Once a suitable vein has been located, the robot applies a tourniquet, prepares the skin, inserts the needle, changes collection tubes, disposes of the needle and applies a bandage. The supervising phlebotomist verifies that tubes have been filled in the correct order and contain sufficient blood.
The system incorporates several safety mechanisms. The skin is continuously disinfected during ultrasound scanning, while the device itself must be cleaned by a trained professional between patients. If a patient moves excessively during collection, the needle automatically detaches and the procedure stops. Other sensors can pause the process and alert the supervisor when potentially unsafe conditions are detected.
Comparable to trained professionals
The FDA based its decision on clinical data showing that, when Aletta proceeded with needle insertion, its successful blood draw rates were comparable to or better than those achieved by trained human phlebotomists. The technology was evaluated in a broad patient population, including people with different health conditions and skin tones as well as participants who reported having difficult vein access. According to the FDA, device related adverse events were uncommon and mild.
Michelle Tarver, Director of the FDA’s Center for Devices and Radiological Health, said the authorization demonstrates how medical technology could help address workforce challenges while maintaining safety and effectiveness. Blood draws are among the most common medical procedures in the United States, making automation potentially relevant for both patient access and healthcare capacity.
Regulatory pathway for new technology
The FDA granted Vitestro marketing authorization through the De Novo pathway, which is intended for new types of low to moderate risk medical devices for which no legally marketed predicate device exists. As part of the authorization, the FDA established specific requirements covering areas including labeling, performance testing and clinical testing. These special controls will also provide a regulatory framework for similar devices that may enter the U.S. market in the future.
For Vitestro, the authorization represents an important step toward introducing autonomous blood collection into routine outpatient care. Although Aletta automates the physical procedure, the current model retains professional oversight. Rather than removing the phlebotomist from the process entirely, the technology could allow trained professionals to supervise several blood draws simultaneously and potentially increase capacity where staffing is limited.
Developed in the Netherlands
Earlier this year we wrote about Aletta being developed and tested in the Netherlands. The blood collection device is a product of Utrecht-based Vitestro and was developed in close collaboration with St. Antonius, the OLVG Lab, Amsterdam UMC and Result Lab. During his keynote speech at the ICT&health World Conference in May 2024, Lucien Engelen gave a live demonstration of the blood collection device.
In the six months prior to April 2026, Aletta was part of a research project at the blood collection centre in Nieuwegein. A large banner drew visitors’ attention to her presence. The research focused on people taking anticoagulant medication and formed part of a large study in which 1,966 patients have participated so far. The vast majority had no objections or were even downright enthusiastic, said Van Holten. He also noted that a number of people were concerned about staff employment. But those people could be reassured. “It’s not at risk. Aletta actually helps to solve staff shortages. Moreover, there will always be a need for someone to support patients; it’s nice for them to see a human face. And there will always be a need for people to take blood samples,” Van Holten said.
References
FDA
