Aletta

von Vitestro

AI Application

Niedrige Vertrauensstufe

Aletta is an autonomous robotic phlebotomy device that draws diagnostic blood samples in hospital blood-collection departments, for patients aged 16 and over. The vendor says it uses near-infrared imaging, ultrasound and Doppler to find a suitable vein and tell veins from arteries, and AI guidance with robotics to position and insert the needle; it then fills the sample tubes and applies a bandage, using a new sterile needle for each patient. A trained phlebotomist decides which patients are suitable, oversees the procedure and can supervise up to three devices, and the patient can press a stop or help button at any time. Aletta was CE-marked under the MDR in July 2024 and received FDA De Novo authorisation in August 2026; the vendor describes it as in clinical and pre-commercial use in Europe, starting with a limited release at selected hospitals. The vendor does not publish the device class or say whether any data leave the device.