FDA Clears First Autonomous Robotic Blood-Draw Device Based on Human-Level Clinical Data

On August 18, 2026, the FDA authorized Vitestro's Aletta, the first autonomous robotic phlebotomy device to receive US clearance. The decision relied on clinical data showing blood-draw success rates comparable to or better than human phlebotomists. Aletta uses near-infrared imaging and Doppler ultrasound for vein location, automating tourniquet application, needle insertion, disposal, and bandaging.