First autonomous blood draw robot authorized by FDA

Clinical takeaway: Expect supervised robotic draws in outpatient labs. Performance in trial use was comparable to trained phlebotomists on attempted sticks, but a human still handles anyone the device screens out. 

Blood draws are among the most common procedures in US medicine, and outpatient throughput often depends on how many trained phlebotomists are on the floor. FDA has authorized Aletta as the first standalone robotic device to perform a blood draw without hands-on operator involvement. It was developed by Dutch startup Vitestro and secured a CE mark in Europe in 2024. The FDA authorization permits one phlebotomy-trained supervisor to run up to three units. 

Here's how it's intended to work. A supervisor loads a cartridge of labeled tubes in the intended draw order. The patient positions an arm, and the patient or supervisor presses a button to start. Near-infrared imaging finds a starting position, then ultrasound scans the area for a suitable vein. Doppler confirms the target is a vein and not an artery, while alcohol sprays the skin throughout the scan. The device applies a tourniquet and, once vein size, depth, and orientation criteria are met, inserts a needle, fills and inverts the tubes then applies a bandage. The supervisor verifies that each tube is adequately full. 

In a clinical trial, this robotic venipuncture succeeded on the first stick in 94.5% of 1,633 outpatients, inside the 93% to 97% range published for trained US phlebotomists. Success held up in patients who described their own veins as difficult (92.7%), those age 65 and older (93.4%), and those with obesity (97.4%). Manual first-stick success in difficult access typically runs 75% to 85%. 

The device attempts a stick only after it identifies a suitable vein, and in 110 of 1,743 patients screened (6%) it found none and sent the patient to a phlebotomist. Counting those patients, overall collection success was 88.5%. 

Adverse events occurred in 0.6% of draws, all mild and self-limiting, most commonly vasovagal reactions. Hemolysis affected 0.3% of samples, below typical laboratory rates. A draw took about 2.5 minutes. Among surveyed patients, 90% rated pain as less than or similar to a manual draw, though 18% still said they would prefer a person next time. 

Published evidence comes from ADOPT, a single-arm, industry-funded trial in three Dutch outpatient phlebotomy departments in 2025, benchmarked against published literature rather than against phlebotomists working alongside the device. The clinical data FDA reviewed for authorization has not yet been published. 

Willingness to use the device was measured in a simulated-use test at one site, where the device scanned for veins but never inserted a needle, and 86% of 78 outpatients said they would accept a robotic draw. Whether that holds once a needle is involved, and once the novelty wears off, is not yet known. 

"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," said Michelle Tarver, MD, PiPhD, director of the FDA's Center for Devices and Radiological Health. 

Sources: Giesen LFP, et al. (2026 Apr 10) Clin Chem. Performance, Safety, and Patient Experience of an Autonomous Robotic Phlebotomy Device: A Multicenter Trial; FDA. (2026 Aug 19) FDA Authorizes First-Of-Its-Kind Robotic Blood Draw Device