First Autonomous Blood-Draw Robot Cleared by FDA

The FDA has authorized Aletta, the first autonomous blood-draw device, developed by Dutch firm Vitestro. The robot could help ease phlebotomist shortages, but questions remain about skin-tone bias and sample quality.

This article was drafted with AI assistance from multiple sources and was reviewed and approved by a human editor before publication.

The U.S. Food and Drug Administration has authorized the first autonomous blood-draw device for use in the country. The device, called Aletta, was developed by the Dutch medical robotics firm Vitestro. The FDA granted clearance on August 19 for use in adults in non-hospitalized settings. European regulators had already authorized the device approximately two years earlier, in 2024.

Aletta uses a combination of near-infrared light, ultrasound, Doppler, and artificial intelligence to locate veins and draw blood. In a clinical trial conducted in the Netherlands involving more than 1,600 people, the device achieved a first-attempt success rate of 94.5%. The trial included individuals with hard-to-access veins, obesity, and elderly patients. When Aletta failed to identify a suitable vein, patients were referred to conventional phlebotomy.

The device is designed to be supervised by a single phlebotomist, who can oversee up to three Aletta machines simultaneously. This could address significant workforce challenges in the profession. Surveys of medical laboratories, mostly in the U.S., indicate a median annual turnover rate of nearly 25% among phlebotomists, with a vacancy rate close to 10%.

Vitestro claims that the technology works for all skin tones, a statement echoed in the FDA's press release. The company says it has unpublished data showing no effect of skin tone on performance, according to a company representative named Giesen. However, independent verification is still pending. Brooke Katzman of the Mayo Clinic, who is collaborating with Vitestro, plans to conduct a U.S.-based trial next year to assess sample quality. "We're going to do our due diligence," Katzman said. "Like any instrument we would bring into the lab, we're going to put it through its paces before using it clinically."

The device is named after Aletta Jacobs, the first female doctor in the Netherlands and founder of the first birth control clinic. Max Balter of Medtronic commented on the achievement: "You have to tip your cap to them. The engineering that they have is incredible… and with their FDA clearance, it moves the whole industry forward." Joe El-Khoury of Yale also praised the device's performance, saying, "It's exceptional performance. It's definitely as good if not better" than typical professional phlebotomists.

While the FDA clearance marks a significant milestone, questions about skin-tone bias and sample quality remain. The company's claims are based on unpublished data, and further trials will be needed to confirm the device's reliability across diverse patient populations.