Vitestro’s Aletta receives FDA authorization for autonomous blood collection

The U.S. Food and Drug Administration (FDA) has granted De Novo authorization to Vitestro’s Aletta, the first standalone robotic device permitted to perform blood draws from a patient’s arm without hands-on operator intervention. The system utilizes near-infrared imaging, ultrasound, and Doppler ultrasound combined with robotic needle guidance to identify veins, determine puncture locations, and collect diagnostic samples.

While the technology allows a single phlebotomist to supervise up to three devices simultaneously, the authorization is currently limited to adults in outpatient settings. Clinical validation indicated that the device’s success rate is comparable to or exceeds that of trained human phlebotomists, even across different skin tones and difficult venous access.

Despite the regulatory milestone, Aletta will not be immediately available to U.S. patients. The Dutch company Vitestro plans to deploy the technology in Europe first and intends to conduct multicenter clinical trials in the United States to validate performance in American clinical settings before a full commercial launch.