The FDA just authorized the first robot that can draw blood on its own

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One phlebotomist can oversee up to three Aletta units at once, which the FDA says may help address a shortage of trained blood draw technicians

Sarah Silbiger / Getty Images

Vitestro received FDA authorization for Aletta, a standalone robotic device capable of drawing blood from a patient's arm without hands-on operator involvement. The FDA granted the authorization through the De Novo pathway, which applies to low- to moderate-risk devices of a new type.

The Aletta is approved for use with adults in outpatient settings and must operate under the oversight of a phlebotomy-trained supervisor. A single phlebotomist can monitor up to three devices simultaneously, which the FDA said may help address the current shortage of trained phlebotomists in the United States.

The device handles each step of a blood draw on its own after a patient or supervisor presses a button to begin. It uses near-infrared light and Doppler ultrasound to locate a suitable vein and distinguish it from arteries. If no appropriate vein is found, the device will not attempt the procedure. Once a vein is identified, the Aletta applies a tourniquet, prepares the skin, inserts and disposes of the needle, swaps collection tubes and places a bandage.

During the procedure, the supervising phlebotomist's responsibilities are confined to ensuring that collection tubes are loaded in the proper sequence and checking that each tube contains a sufficient volume of blood when the draw is complete. A trained professional must clean the device between patients.

According to the FDA, clinical data supporting the authorization showed that Aletta's success rate on attempted draws was on par with — or exceeded — that of human phlebotomists. The agency said the results held across a broad range of patients, including those with self-reported difficult vein access and those with varying skin tones. Device-related adverse events were described as uncommon and mild.

"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," Michelle Tarver, M.D., Ph.D., Director of the FDA's Center for Devices and Radiological Health, said in a statement.

As part of the De Novo authorization, the FDA put in place special controls around labeling, performance, and clinical testing that future robotic blood draw products can use as a basis for seeking the more streamlined 510(k) clearance, the agency said.

The device earned a CE mark in 2024, after which Vitestro began selling it on a limited basis in Europe, according to MedTech Dive. Vitestro raised $70 million in March to support U.S. market entry, manufacturing expansion and commercial infrastructure development.

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