FDA authorizes first robot that draws blood without a phlebotomist's hands
The FDA granted De Novo authorization to Vitestro's Aletta, the first standalone robotic device authorized to draw blood from a patient's arm without hands-on operator intervention. The system uses near-infrared imaging and ultrasound to locate a vein, then applies a tourniquet, preps the skin, inserts the needle, fills tubes, and applies a bandage on its own, with automatic needle detachment if the patient moves excessively. It is authorized for adults in outpatient settings, with one trained phlebotomist able to supervise up to three devices at once. The FDA said clinical data showed success rates comparable to or better than human phlebotomists, including in patients with difficult venous access.
Why it's notable: It is the first FDA authorization for an autonomous device performing a hands-on clinical procedure on patients, and it targets a chronic staffing bottleneck in outpatient labs and clinics.