FDA Clears First Autonomous Robotic Blood-Draw Device

FDA Clears First Autonomous Robotic Blood-Draw Device

On August 18, 2026, the FDA authorized Vitestro's Aletta, the first autonomous robotic phlebotomy device cleared in the US. Clinical data showed blood-draw success rates matching or exceeding human phlebotomists. Aletta combines near-infrared imaging and Doppler ultrasound to locate veins, then automates tourniquet application, needle insertion, disposal, and bandaging.

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