A patient gets blood drawn by the Aletta, an autonomous blood-drawing robot that just received FDA authorization.
Norbert Waalboer Fotografie
The next time you go for a blood test, it could be a robot finding your vein and sticking a needle in it. The Food and Drug Administration last week authorized the Aletta, a standalone robotic device that can autonomously draw blood. The agency says the bot could eventually help laboratories deal with staffing shortages and reduce the time it takes for patients to complete routine blood work.
“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, director of the FDA’s Center for Devices and Radiological Health, said in a statement announcing the authorization of the robot in outpatient settings.
The robot from Dutch startup Vitestro is already drawing blood from patients at hospitals and laboratories in Europe as part of a clinical trial.
When patients sit next to the machine, it guides them to position their arm for the needle stick. The machine then uses near-infrared light and real-time ultrasound imaging to find a suitable vein and confirm it’s not an artery. The robot performs each step of the blood draw — it applies a tourniquet, sanitizes the skin, inserts the needle, swaps blood collection tubes and puts on a bandage once the draw is complete.
Humans Still Needed
But while the Aletta functions without a hands-on human operator, it isn’t eliminating the need for human expertise — at least not yet. The machine must be overseen by a supervisor trained in phlebotomy who initiates the blood-drawing session with the press of a button and confirms that collection tubes are filled in the right order and contain a sufficient amount of blood. The professional also disinfects the machine between patients.
One phlebotomist can oversee up to three Aletta devices at a time, potentially freeing up staff to attend to patients who need more personalized attention.
A 2024 survey by the American Society for Clinical Pathology seeking to determine the extent and distribution of workforce shortages within U.S. medical laboratories found a 9.4% vacancy rate in phlebotomy, including a 9.9% vacancy rate for staff positions. The survey of U.S. medical laboratories also found that night and overtime shifts were hard to fill, with double shifts even more so.
The FDA granted the authorization through its De Novo pathway, which applies to new types of devices that carry a low to moderate risk.
Safety Sensors Included
The Aletta comes with built-in safety checks. The robot is equipped with sensors that can detect if a patient moves enough to make the procedure unsafe, in which case the needle automatically detaches and the blood draw halts. If the machine can’t find an appropriate vein, it won’t move ahead with the procedure.
The Aletta isn’t the first robot designed to automate part of the blood-drawing process. California startup Veebot, for example, is developing a robotic system that also uses imaging to locate veins and insert a needle. Aletta differs in that it’s the first standalone robotic blood-draw device authorized by the FDA.
The FDA’s authorization of the Aletta is based on clinical data showing that the robot achieves successful blood draw rates “comparable to or better than trained human phlebotomists when it proceeds with a stick.”
“This was demonstrated across a broad range of patients, including those with varying health statuses, those who self-reported having difficult vein access and those with varying skin tones,” the FDA said. “Device-related adverse events were uncommon and mild.”
A peer-reviewed study on the device’s performance published in April in the journal Clinical Chemistry reported that in tests of 1,633 patients at three outpatient labs, the overall first-stick success rate was 94.5 percent when the machine located a suitable vein.
Prior to FDA authorization, the Aletta received the CE mark, which indicates a product complies with applicable European Union requirements for health, safety and environmental protection.
Neither the CE mark nor FDA authorization guarantee widespread clinical use, but they mark another step toward robots taking on healthcare tasks — from performing surgery to delivering medications to helping restore mobility.
Still there are things medical robots can’t do. When I had blood drawn on Friday, the phlebotomist complimented me on my easy-to-find veins. Let’s face it: The Aletta may be able to find a good vein, but it probably won’t tell you you have nice ones.