FDA clears Vitestro's Aletta, first robotic blood draw device for U.S. clinics

The U.S. Food and Drug Administration has granted clearance to Vitestro's Aletta, making it the first standalone robotic system approved to draw blood without direct human handling.

Aletta can perform the full draw-from applying a tourniquet to placing a bandage-while a phlebotomist supervises up to three units, helping to ease the nationwide shortage of phlebotomists in outpatient settings.

The robot uses combined near-infrared and ultrasound imaging to locate veins and Doppler ultrasound to verify vein selection. In a pivotal trial it achieved a 94.5% first-stick success rate, and most patients reported pain equal to or less than a manual draw.

Aletta has been on the European market for two years and the company recently raised $70 million in a Series B round, backed by investors such as Labcorp Venture Fund, Mayo Clinic and Sutter Health, to scale manufacturing and expand clinical use in the United States.