FDA Authorizes Robotic Blood Draw Device

The Food and Drug Administration authorized the Aletta (Vitestro), the first standalone robotic device designed to draw blood from a patient’s arm without hands-on operator intervention. The device is authorized for use in adults in outpatient settings under the oversight of a supervisor trained in phlebotomy. It is not authorized for use in blood donation.

Aletta uses near-infrared light and Doppler ultrasound to locate a suitable vein and distinguish it from arteries before autonomously completing the blood draw, including applying a tourniquet, preparing the skin, inserting and disposing of the needle, changing collection tubes and placing a bandage. A trained phlebotomist initiates each session and remains available to respond to issues and verify that the collection tubes are properly filled. One phlebotomist can oversee up to three Aletta devices simultaneously.

FDA based the authorization on clinical data showing that Aletta achieved successful blood draw rates that were comparable to or better than those of trained phlebotomists when it proceeded with a needle stick. Device-related adverse events were uncommon and mild.

FDA granted marketing authorization through the De Novo pathway for low- to moderate-risk devices of a new type. The agency is also establishing special controls that define requirements related to labeling, performance testing and clinical testing.