FDA authorizes first standalone robotic device to draw blood
The U.S. Food and Drug Administration has authorized Aletta as the first standalone robotic device that can draw blood from a patient's arm. Marketing authorization was granted to Vitestro.
The U.S. Food and Drug Administration (FDA) recently granted approval to Aletta, marking the first standalone robotic device capable of drawing blood from a patient's arm without direct human intervention. Vitestro secured the marketing authorization for this pioneering technology. Designed for use in adult outpatients, the device requires supervision by a trained phlebotomist throughout the process.
A single phlebotomist can manage up to three Aletta units simultaneously, initiating each session and addressing any issues that arise, while Aletta autonomously manages every step of the blood draw.
Utilizing near-infrared light and Doppler ultrasound technology, Aletta accurately identifies a suitable vein and then proceeds to perform the remaining steps independently. These steps include applying a tourniquet, preparing the skin, inserting and disposing of the needle, changing collection tubes, and applying a bandage. Following the automated process, the supervising phlebotomist verifies that the collection tubes are filled in the correct order and ensures that all tubes are adequately full.
The FDA's authorization is based on robust clinical data demonstrating that Aletta achieves blood-draw success rates that are equal to or surpass those of trained human phlebotomists. The trials involved a diverse range of patients, including those with self-reported difficult vein access and varying skin tones. Notably, device-related adverse events were uncommon and mild, indicating a high level of safety.
This authorization underscores the FDA's dedication to fostering medical innovations that address critical public health needs while upholding the safety and efficacy standards patients require. Michelle Tarver, M.D., Ph.D., from the FDA Center for Devices and Radiological Health, emphasized in a statement that blood draws are among the most frequently performed medical procedures in the United States, yet they often face delays due to a shortage of trained phlebotomists.
The FDA's authorization of Aletta as the first robotic blood draw device underscores its commitment to advancing healthcare technology while maintaining rigorous standards of safety and effectiveness.
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