A fully autonomous robotic system designed to perform blood draws has cleared a major clinical hurdle, showing a first-stick success rate of 94.5 percent across more than 1,600 patients in a multicenter trial. The device, called Aletta, uses advanced imaging and artificial intelligence to locate veins and insert the needle without human hands, offering a potential solution to staffing shortages and inconsistent sample quality in busy clinics.
The peer-reviewed study, published in Clinical Chemistry, enrolled 1,633 patients across three outpatient phlebotomy departments in the Netherlands. When a suitable vein was identified, the robot succeeded on its first attempt in 94.5 percent of cases. Crucially, performance held steady in groups that often challenge human phlebotomists. In patients with a body mass index above 30 kg/m², the success rate reached 97.4 percent. For those who self-reported difficult venous access, it was 92.7 percent, and in patients older than 65, it was 93.4 percent.
The trial also reported a hemolysis rate of just 0.3 percent, which is lower than rates typically seen with manual draws, and an adverse event rate of 0.6 percent, with all events classified as mild. Patient comfort was a notable highlight. According to the study, 90 percent of participants said their pain levels were less than, far less than, or similar to what they had experienced with manual phlebotomy. Additionally, 82 percent said they would prefer the robotic system in the future or had no preference. A separate patient acceptance study at Mayo Clinic in Rochester, Minnesota, found that 86 percent of patients were willing to use the device for their blood draw.
The Aletta system relies on multimodal imaging to guide its work. It combines near-infrared vein visualization, real-time ultrasound, and Doppler ultrasound to distinguish between veins and arteries. Artificial intelligence then directs the robotic arm to select a suitable vein and insert the needle for collection. This standardized approach could reduce the variability that often affects the preanalytical phase of lab testing, which is the stage where many errors originate.
Robert de Jonge, PhD, professor and head of the department of laboratory medicine at Amsterdam University Medical Center, called the study a significant milestone in validating robotic phlebotomy in routine practice. Thijs van Holten, PhD, a clinical chemist at St Antonius Hospital, noted that the system introduces a consistent method for blood collection, which could improve sample quality and support more reliable diagnostic outcomes.
The device is already CE-marked and in use in Europe, but it has not yet received Food and Drug Administration authorization for use in the United States. The company behind Aletta plans to continue building the evidence base, and researchers are optimistic that this technology could soon help ease the burden on overstretched phlebotomy teams while improving the patient experience. For now, the trial results offer a clear signal that robotic blood draws are no longer a futuristic concept, but a clinically viable option on the horizon.