FDA authorizes Aletta robotic blood draw device

The U.S. Food and Drug Administration (FDA) has authorized Aletta, the first standalone robotic device designed to perform blood draws from a patient’s arm without direct hands-on intervention. Developed by the medical robotics company Vitestro, the device is intended for use on adults in outpatient settings.

Aletta utilizes near-infrared light and Doppler ultrasound to locate suitable veins while distinguishing them from arteries. Once a vein is identified, the system autonomously performs several steps, including applying a tourniquet, preparing the skin, inserting and disposing of the needle, changing collection tubes, and applying a bandage. If the system cannot identify a suitable vein, it will not attempt the procedure.

To ensure safety, the device must operate under the supervision of a trained phlebotomist, who initiates the session and remains available to intervene. One phlebotomist can supervise up to three Aletta devices simultaneously. The FDA noted that this authorization addresses a critical public health need caused by a shortage of trained phlebotomists. Clinical tests indicated that Aletta’s success rates are comparable to, or even exceed, those of professional technicians across diverse patient populations.