Aletta is the first autonomous blood-draw machine approved by the U.S. Food and Drug Administration for use in nonhospital settings.
You sit down and put your arm in the cradle. You press a button. The machine takes it from there.
Anear-infrared lightsweeps your inner elbow, hunting for a vein. A puff of alcohol hits your skin. Anultrasoundprobe glides across your arm, mapping how deep the vessel runs and which way it bends. Doppler captures the direction of blood flow to rule out the artery.
The cuff tightens around your upper arm. The needle comes down and pierces the skin. Your blood flows into the collection tubes, each one tipped end over end nine times—no more, no less. The needle withdraws. You get a bandage. No human ever touched you.
This is what it’s like to have blood taken byAletta, the firstautonomous blood-draw deviceauthorized for use in theUnited States. Developed by the Dutchmedical roboticsfirmVitestro, the system combines imaging technologies with advancedroboticsand AI to do by algorithm what a human phlebotomist—a trained health care professional who finds veins and draws blood by hand—does by feel.
The U.S. Food and Drug Administrationgave Aletta the go-aheadon 19 August for use on adults in nonhospitalized settings. The decision follows the lead of European regulators, whoauthorized the device two years earlier.
“You have to tip your cap to them,” saysMax Balter, a surgical-robotics specialist at Medtronic whoworkedonautonomousblood-drawsystemsduring grad school in the mid-2010s. “The engineering that they have is incredible…and with their FDA clearance, it moves the whole industry forward.”
In a clinical trial involving more than 1,600 people in the Netherlands, Aletta successfully drew blood on the first attempt in94.5 percent of cases, even among those with hard-to-access veins, people with obesity, and the elderly. When Aletta failed to identify a suitable vein, the patient was referred for conventional phlebotomy.
“It’s exceptional performance,” saysJoe El-Khoury, a clinical chemist at Yale who was not involved in the Dutch trial. “It’s definitely as good if not better” than a typical professional phlebotomist.
Complications were minimal, with multiple built-in safeguards to detect problems, such as sensors that track arm movement and needle position, and to halt the process should something go awry. And for those whose veins proved too challenging, a phlebotomist remains on hand to take over when needed.
Notably, because a single phlebotomist can supervise up to three Aletta machines, the system should go a long way toward “helping clinical labs address the critical operational challenges related to the staffing shortages of phlebotomists,” saysLuuk Giesen, chief medical officer of Vitestro.
That’s no small challenge in a profession with amedian annual turnover rate of nearly 25 percentand avacancy rate of close to 10 percent, according to surveys of medical laboratories that draw mostly from U.S. institutions. The resulting staffing shortages can limit labs’ capacity to meet demand for routine diagnostic testing of blood counts, cholesterol, metabolic markers, and more. Aletta could address that bottleneck.
The promise of greater capacity, however, comes with a caveat: Aletta still fails in roughly one case out of 20. Who are those people?
Some may simply have elusive or unusually deep veins. But a more significant obstacle could be skin pigmentation. In particular, the melanin in darker skin can interfere with the near-infrared light Aletta uses to first map the veins near the skin’s surface and identify promising puncture sites. The technique relies on hemoglobin absorbing the light differently from surrounding tissue, and darker skin tones can absorb more of that light before it…
Some experts have raised concerns that Aletta’s infrared sensors will perform poorly for people with darker skin tones, but Vitestro says that its machine also includes an ultrasound sensor, in part to mitigate that risk.Vitestro
Giesen recognizes that the issue could affect first-pass imaging, but notes that the main determinant of vein selection and needle placement is the ultrasound system, which relies on sound rather than light and should not be affected by skin pigmentation in the same way. “Ultrasound is skin-tone agnostic,” he says, adding that Vitestro has unpublished data showing no effect of skin tone on the system’s performance.
The company thusclaims on its websitethat the “technology works well for all skin tones,” an assertionechoed in the FDA press releaseannouncing the authorization of Vitestro’s device.
But given the history of racial disparities in medical devices—particularly optical technologies such as pulse oximeters, which can beless accurate in people with darker skinand went largely unrecognized as a problem for decades—such claims warrant evidence, says El-Khoury, who haswritten about the issue.
Brooke Katzman, a clinical chemist at the Mayo Clinic who is collaborating with Vitestro, also wants more evidence that samples collected by the robot are as suitable for testing as those drawn by hand.
The Dutch trial reported little damage to red blood cells, but other measures of sample quality, including clotted tubes, insufficient blood, and proper tube filling, still need to be assessed, as do the results of routine laboratory tests themselves. Katzman plans to launch a U.S.-based trial next year to collect just that sort of data.
“We’re going to do our due diligence,” she says. “Like any instrument we would bring into the lab, we’re going to put it through its paces before using it clinically.”
Aletta takes its name from the 19th-century physicianAletta Jacobs, the first female doctor in the Netherlands and founder of what is widely considered the world’s first birth-control clinic.
That nod to history is fitting for a technology that builds on decades of research in robotic phlebotomy by groups inEurope, theUnited States, andChina, andMagicNurse. Yet few pushed the concept as far as biomedical engineerMartin Yarmushof Rutgers University in New Jersey, in whose lab Medtronic’s Balter completed his Ph.D.
In one version of their platform, the Rutgers team evencoupled their robot to a benchtop blood analyzer, allowing it to draw samples and then measure levels of infection-fighting immune cells and oxygen-carrying red blood cells—all within minutes.
That all-in system never made it out of laboratory testing. And VascuLogic, the company spun out to commercialize the platform, is long defunct—though others, includingROPHAI,BHealthCare, andMagicNurse, continue to work in the space. But the Rutgers proof-of-concept demonstration points toward the tantalizing possibility of fully automated blood testing at the point of care, with robots handling everything from the needle stick to the analysis.
It is, in some ways, the promise that Theranos made—but built on conventional, validated laboratory technology rather than thedubious science and deceptionthat brought that particular company down.
“I have no doubt that is the future,” saysGregory Retzinger, a clinical pathologist at the Northwestern University Feinberg School of Medicine, in Chicago, whocollaborates with Vitestroand has tried the Aletta device himself. (“It was painless, it was fast,” he says.)
For now, Giesen says Vitestro is keeping its ambitions—and its machine—focused on the blood-collection process itself, though he believes Aletta could ultimately do far more. The company plans to launch Aletta in Europe next year, with the U.S. market to follow.
Elie Dolginis a science writer specializing in biomedical research and drug discovery. After a PhD spent studying the population genetics of nematodes, he swapped worms for words—entering journalism as an editor atThe Scientist,Nature Medicine, andSTAT. Now a freelancer, Elie is a frequent contributor toNew Scientist,Nature,IEEE Spectrum, and more.