The U.S. Food and Drug Administration has given the green light to Aletta, a groundbreaking robotic system capable of performing blood draws entirely on its own — marking the first time regulators have approved a fully autonomous venipuncture device for real-world clinical use.
Built by Vitestro, the machine relies on a combination of near-infrared imaging and Doppler ultrasound technology to pinpoint a viable vein in a patient’s arm while distinguishing it from nearby arteries. Once a session begins, Aletta independently manages the entire procedure — securing a tourniquet, sterilizing the injection site, inserting the needle, swapping out sample tubes, and finishing with a bandage — all without a technician’s hands touching the patient.
Safety remains built into the design: the unit continually sanitizes the skin throughout scanning, and if a patient shifts position unexpectedly, the needle disengages automatically and the process halts. Sensors are also programmed to flag irregular conditions and pause operation until a supervising phlebotomist intervenes.
Regulators cleared the device for outpatient use in adults, requiring that a certified phlebotomist remain present to launch each session and stay available throughout. Notably, one supervisor can watch over as many as three Aletta units running simultaneously — a feature health officials say could meaningfully ease staffing pressures in an industry currently facing a phlebotomist shortfall.
FDA officials noted that clinical trial results showed the robot’s draw success rate held up against — and in some cases surpassed — that of experienced human phlebotomists, with side effects reported as both rare and minor. The agency framed the approval as part of its broader push to expand access to essential diagnostic services through innovative medical technology.
Written By: Sayan Das
Graphics by: Pramit Hazra
