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\u2014no more, no less. The needle withdraws. You get a bandage. No human ever touched you.<\/p>\n
This is what it\u2019s like to have blood taken by Aletta<\/a>, the first autonomous blood-draw device<\/a> authorized for use in the United States<\/a>. Developed by the Dutch medical robotics<\/a> firm Vitestro<\/a>, the system combines imaging technologies with advanced robotics<\/a> and AI to do by algorithm what a human phlebotomist\u2014a trained healthcare professional who finds veins and draws blood by hand\u2014does by feel.<\/p>\n The U.S. Food and Drug Administration gave Aletta the go-ahead<\/a> on 19 August for use on adults in non-hospitalized settings. The decision follows the lead of European regulators, who authorized the device two years earlier<\/a>.<\/p>\n \u201cYou have to tip your cap to them,\u201d says Max Balter<\/a>, a surgical robotics specialist at Medtronic who worked<\/a> on autonomous<\/a> blood-draw systems<\/a> during grad school in the mid-2010s. \u201cThe engineering that they have is incredible\u2026 and with their FDA clearance, it moves the whole industry forward.\u201d<\/p>\n Aletta Boosts Lab Capacity Amid Shortages<\/p>\n In a clinical trial involving more than 1,600 people in the Netherlands, Aletta successfully drew blood on the first attempt in 94.5 percent of cases<\/a>, 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.<\/p>\n \u201cIt\u2019s exceptional performance,\u201d says Joe El-Khoury<\/a>, a clinical chemist at Yale who was not involved in the Dutch trial. \u201cIt\u2019s definitely as good if not better\u201d than a typical professional phlebotomist.<\/p>\n Complications were minimal, with multiple built-in safeguards to detect problems, such as sensors that track arm movement and needle position, and 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.<\/p>\n Notably, because a single phlebotomist can supervise up to three Aletta machines, the system should go a long way toward \u201chelping clinical labs address the critical operational challenges related to the staffing shortages of phlebotomists,\u201d says Luuk Giesen<\/a>, chief medical officer of Vitestro.<\/p>\n That\u2019s no small challenge in a profession with a median annual turnover rate of nearly 25 percent<\/a> and a vacancy rate of close to 10 percent<\/a>, according to surveys of medical laboratories that draw mostly from U.S. institutions. The resulting staffing shortages can limit labs\u2019 capacity to meet demand for routine diagnostic testing of blood counts, cholesterol, metabolic markers, and more. Aletta could address that bottleneck.<\/p>\n Addressing Skin Tone Bias in Blood Draw AI<\/p>\n The promise of greater capacity, however, comes with a caveat: Aletta still fails in roughly one case out of 20. Who are those people?<\/p>\n 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\u2019s 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 reaches the camera, thereby reducing the contrast.<\/p>\n Giesen recognizes 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. \u201cUltrasound is skin-tone agnostic,\u201d he says, adding that Vitestro has unpublished data showing no effect of skin tone on the system\u2019s performance.<\/p>\n The company thus claims on its website<\/a> that the \u201ctechnology works well for all skin tones,\u201d an assertion echoed in the FDA press release<\/a> announcing the authorization of Vitestro\u2019s device.<\/p>\n But given the history of racial disparities in medical devices\u2014particularly optical technologies such as pulse oximeters, which can be less accurate in people with darker skin<\/a> and went largely unrecognized as a problem for decades\u2014such claims warrant evidence, says El-Khoury, who has written about the issue<\/a>.<\/p>\n Brooke Katzman<\/a>, 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.<\/p>\n 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.<\/p>\n \u201cWe\u2019re going to do our due diligence,\u201d she says. \u201cLike any instrument we would bring into the lab, we\u2019re going to put it through its paces before using it clinically.\u201d<\/p>\n The Future of Automated Blood Testing<\/p>\n Aletta takes its name from the 19th-century physician Aletta Jacobs<\/a>, the first female doctor in the Netherlands and founder of what is widely considered the world\u2019s first birth control clinic.<\/p>\n That nod to history is fitting for a technology that builds on decades of research in robotic phlebotomy by groups in Europe<\/a>, the United States<\/a>, and China<\/a>, and MagicNurse<\/a>. Yet few pushed the concept as far as biomedical engineer Martin Yarmush<\/a> of Rutgers University in New Jersey, in whose lab Medtronic\u2019s Balter completed his Ph.D.<\/p>\n In one version of their platform, the Rutgers team even coupled their robot to a benchtop blood analyzer<\/a>, allowing it to draw samples and then measure levels of infection-fighting immune cells and oxygen-carrying red blood cells\u2014all within minutes.<\/p>\n That all-in system never made it out of laboratory testing. And VascuLogic, the company spun out to commercialize the platform, is long defunct \u2014 though others, including ROPHAI<\/a>, BHealthCare<\/a>, and MagicNurse<\/a>, 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.<\/p>\n It is, in some ways, the promise Theranos made\u2014but built on conventional, validated laboratory technology rather than the dubious science and deception<\/a> that brought that particular company down.<\/p>\n \u201cI have no doubt that is the future,\u201d says Gregory Retzinger<\/a>, a clinical pathologist at the Northwestern University Feinberg School of Medicine in Chicago who collaborates with Vitestro<\/a> and has tried the Aletta device himself. (\u201cIt was painless, it was fast,\u201d he says.)<\/p>\n For now, Giesen says Vitestro is keeping its ambitions\u2014and its machine\u2014focused 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. <\/p>\n From Your Site Articles<\/p>\n Related Articles Around the Web<\/p>\n","protected":false},"excerpt":{"rendered":"You sit down and put your arm in the cradle. You press a button. 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