The FDA has approved Vitestro's Aletta as the first standalone robotic device in the U.S. designed to draw blood without the need for hands-on human help.
Aletta performs the entire blood draw on its own, from placing the tourniquet to applying the bandage.
To locate a suitable vein, Aletta uses multimodal imaging that combines near-infrared and ultrasound.
The device also uses Doppler ultrasound to confirm it has selected a vein and not an artery.
In a key trial, the device showed a 94.5% first-stick success rate, with 90% of those in the study seeing pain levels for Aletta that were lower or similar to a manual blood draw.
The robot still requires oversight from a phlebotomist, but one specialist can oversee up to three devices at once, easing pressure on blood draws in an outpatient setting.
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