On August 19, 2026, the US Food and Drug Administration authorized Aletta, the first standalone robotic device that can draw blood from a person's arm without a technician's hand on the needle. It is made by Vitestro and cleared for adults in outpatient clinics.
In the clinical data submitted to the agency, Aletta's success rate on attempted needle sticks matched or exceeded that of trained phlebotomists, including in people who reported difficult veins and in patients across a range of skin tones. Device-related adverse events were uncommon and mild.
How the machine finds a vein
Aletta uses near-infrared light together with Doppler ultrasound to locate a suitable vein and distinguish it from a nearby artery. Once the system confirms an appropriate target, it applies the tourniquet, prepares the skin and inserts the needle without operator hands.
The robot then swaps collection tubes, withdraws the needle and places a bandage.
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Disinfectant is applied continuously during ultrasound scanning. If the sensors detect excessive patient movement, the needle automatically detaches. The device declines the procedure if no suitable vein is found.
Success rates and supervision
A multicenter study reported by the manufacturer showed a 94.5 percent first-stick success rate when a suitable vein was identified, with a hemolysis rate of 0.3 percent.
Hemolysis refers to red blood cells that rupture during collection, which can render a sample unusable.
One phlebotomist can oversee up to three Aletta devices at the same time, verifying tube sequencing and confirming that enough blood was collected.
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Michelle Tarver, MD, PhD, who directs the FDA's Center for Devices and Radiological Health, said blood draws are one of the country's most common medical procedures and that patients often face delays because of a growing shortage of trained phlebotomists.
What patients can expect
The authorization applies only to adults treated in outpatient settings, and any deployment requires a trained supervisor on site.
Vitestro's device already carries CE marking in Europe, and the company raised 70 million dollars in March 2026 to fund manufacturing and its US entry.
A US multicenter clinical trial is planned before commercial availability in American clinics.
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This article is made and published by Mie Hermansen, who may have used AI in the preparation.