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Getting the latest healthcare news for you
The FDA has authorized Aletta, the first standalone robotic device capable of independently drawing blood from adult patients without hands-on operator intervention. Developed by Dutch company Vitestro, the system uses near-infrared light and Doppler ultrasound to locate veins and autonomously completes the full blood draw — all under phlebotomist supervision. One phlebotomist can oversee up to three devices at once, a potential game-changer amid a growing phlebotomist shortage.
The FDA has granted de novo authorization to Aletta, a robotic blood draw device developed by Dutch company Vitestro — marking the first time a standalone system has been cleared to perform venipuncture on adult patients without direct manual intervention. The device uses near-infrared light and Doppler ultrasound to identify a suitable vein, then autonomously applies a tourniquet, preps the skin, inserts and disposes of the needle, swaps collection tubes, and applies a bandage. A trained phlebotomist initiates each session and can supervise up to three devices simultaneously, directly addressing the growing U.S. shortage of phlebotomy professionals.
Clinical data from a multicenter trial across outpatient phlebotomy departments in the Netherlands showed strong performance, with Aletta achieving a 94.5% first-attempt success rate when it identified a suitable vein. Patient acceptance was also high — 82% said they preferred the robot over a human draw or had no preference.
By the Numbers:
Why it matters: Beyond Aletta itself, the FDA's de novo clearance establishes a new regulatory category and sets the template for future robotic phlebotomy devices — signaling a broader shift toward physical automation in direct patient-care tasks.
