FDA authorizes Aletta, first standalone robotic device for automated blood draws

The U.S. Food and Drug Administration announced it has authorized Aletta, a robotic system that can draw blood without hands‑on operator involvement.

The device is cleared for adult use in outpatient settings and must be overseen by a phlebotomist trained in the procedure. One phlebotomist can supervise up to three Aletta units, a feature that could help mitigate the current shortage of phlebotomists.

Aletta positions the patient’s arm, then uses near‑infrared light and Doppler ultrasound to locate a suitable vein and will not attempt a draw if none is found. The phlebotomist starts each session and remains available to intervene if needed.

FDA officials said the approval reflects a commitment to innovative medical devices that address critical public health needs while maintaining safety and effectiveness.