ROBBRIEF
Vitestro's Aletta uses ultrasound and AI to find a vein and draw blood on its own, but a trained phlebotomist stays in the loop and can oversee up to three devices at a time.
On August 19, the FDA authorized the first fully autonomous blood-draw device for U.S. outpatient clinics, clearing Aletta, an autonomous robotic phlebotomy device built by Dutch firm Vitestro. The De Novo decision creates a new device classification with special controls that will govern every future robotic phlebotomy submission.
Aletta uses near-infrared light, ultrasound, and Doppler imaging to find a vein, distinguish it from an artery, apply a tourniquet, prepare the skin, and insert the needle. A trained phlebotomist (the clinical staff member who draws blood) stays in the loop: one supervisor can oversee up to three Aletta devices at once, which the FDA framed as a way to ease a documented U.S. shortage of trained phlebotomists.
The performance data comes from the Netherlands, not the U.S. In a 1,600-person Dutch trial, Aletta successfully drew blood on the first attempt 94.5% of the time across cohorts that are usually hard to stick, including elderly patients, people with obesity, and difficult-access veins. When no suitable vein is found, the device refuses the attempt and refers the patient for conventional phlebotomy. The cleared use case is also limited to non-hospitalized adults.
European regulators authorized Aletta roughly two years earlier. U.S. commercial rollout trails that timeline: Vitestro has not yet priced the device for American clinics, and a U.S. multicenter trial is planned before broad availability.